8 Quality Director jobs in Australia

Quality Director

Moorabbin, Victoria PCI Pharma Services

Posted 23 days ago

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Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**_Purpose:_**
The Quality Director is responsible for overseeing and managing all quality and regulatory/licencing functions for the PCI Pharma Services (PCI) Melbourne site. This includes appropriate resourcing, and day to day operations, required for compliance to Good Manufacturing Practice, Controlled Substances (Poisons) and the importation/exportation of investigational products.
This position is responsible for the performance of the Quality Department, and is the Quality/Regulatory lead pertaining to the delivery of the PCI Site and Global strategic goals and objectives to achieve commercial success and overall compliance. This role is a conduit between site Quality and Global PCI Quality, facilitating communication, collaboration and issue resolution on global issues and projects with other PCI Global Leaders.
**_The primary responsibilities & tasks of this position are:_**
+ Ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives
+ Ensure there are adequate resources and that roles, responsibilities, and authorities are defined, communicated and implemented for the Quality department
+ Oversee the implementation and compliance of the Pharmaceutical Quality System at PCI Melbourne, including the ePQS. This includes (but is not limited to) Deviation Management, Customer Complaints, CAPA, Training, Change Control, Supplier Management, Document Management (including retention of records and data integrity), Internal Audits, Risk Management and improvements to other GMP software systems as required
+ Oversee and approve PQS improvements, including (but not limited to) procedures and processes for the evaluation, assessment and disposition of suppliers, deviations, change controls, complaints and CAPA
+ Oversee and approve the Periodic Quality Management Review, and oversee monitoring of the ePQS to ensure site and global metrics are met and/or exceeded
+ Develop and communicate the Quality key performance indicators and promote the Quality objectives for site awareness and action as appropriate
+ Oversee and approve/reject quality investigations related to deviations, customer complaints and nonconformances using root cause analysis tools to ensure appropriate investigation, determination of resolution and disposition
+ Ensure validation/qualifications are completed in a timely manner and that appropriate systems are in place for the evaluation of equipment and their maintenance
+ Oversee systems and approve quality contracts for clients and suppliers
+ Oversee the management of regulatory licences, to ensure licences are appropriate and current
+ Oversee inspection and audit preparedness including training, reviews and licence compliance adherence
+ Host and participate in regulatory inspections and client audits and in the preparation of the response as required
+ Engage with clients/sponsors and address client/sponsor queries (and client representatives) to enable product information transfers and compliance to clinical trial protocols and regulatory requirements
+ Oversee the management of the Authorised Persons programme to ensure compliance and effective 'Release for Supply' of product
+ Oversee the management, and the review and approvals of, materials and products, and perform disposition of materials and products. This may include (but is not limited to) incoming goods, manufactured materials/products and returns of materials/products
+ Oversee systems to ensure all necessary testing is carried out, and supporting documents are approved (including but not limited to: specifications, sampling instructions, methods, and quality/operational procedures)
+ Oversee systems to ensure stability testing and/or the assessment of results (in line with ICH requirements) are completed to support shelf life extensions and expiry dates
+ Escalate critical issues and raise 'Quality Bulletins' as appropriate for local and/or global awareness to promote the review and timely correction / CAPA at the affected site, and/or other PCI sites
+ Oversee recall activity and act as a representative for client recall activity, including mock recall compliance.
+ Manage and approve the Quality Department budget (as defined) to ensure costs are controlled and planned in line with site financials and budget
+ Manage and drive continuous improvements to assist in enhancements in departmental operational performance, compliance to regulatory requirements, improvements in site Standard Operating Procedures (SOPs) and meeting external and internal customer requirements, with respect to quality, service, and lead time.
+ Provide direction and expertise to employees to ensure the development and implementation of departmental SOPs that are compliant to regulatory requirements and are 'fit for purpose' operationally and commercially.
+ Participate in the PCI Centres of Excellence as appropriate with the goal of harmonising quality systems across all PCI sites as part of the company's One PCI policy.
+ Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.
+ Ensure timely and effective communication and escalation processes to raise quality issues to the VP of Clinical Quality and the Site Leadership Team
+ Other duties as advised by the VP of Clinical Quality
**_The mandatory qualifications & experience:_**
+ Bachelor of Science, Pharmacy or related Discipline
+ 10+ yrs experience in cGMP pharmaceutical manufacturing facility, in a Quality Assurance or Quality Control leadership role.
+ Excellent written and verbal skills with good attention to detail
+ Documented cGMP training
+ Exceptional verbal and written communication skills
+ Proven coaching and influencing skills at all levels
+ Resourceful, Role Model, Courage to Challenge, Results Driven, Approachable and Innovator
+ Previous experience/working knowledge of contract manufacturing (preferred)
**_Working relationships:_**
The position will report to the VP Global Quality, Clinical Services and will work closely with the VP of the Asia Pacific Region and Senior Leadership Team at PCI Melbourne. In addition to this, the Quality Director will work closely with local and global, internal and external stakeholders including (but not limited to): Project Management, Finance, Production, Warehouse, Human Resources Engineering/Maintenance and regulatory bodies (as required).
#LI-AK2
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
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Director, Commercial Quality - ANZ & APAC

Sydney, New South Wales Teva Pharmaceuticals

Posted 2 days ago

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Director, Commercial Quality - ANZ & APAC
Date: Aug 21, 2025
Location:
Sydney, Australia, 2113
Company: Teva Pharmaceuticals
Job Id: 63067
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
This dual-role position serves as the Commercial Quality Assurance (CQA) Lead for ANZ and APAC, responsible for ensuring the compliant, efficient, and customer-focused distribution of Teva products across multiple APAC markets. Working in alignment with General Managers in each country, the role sets clear directions by generating a forward-looking perspective for quality assurance, providing strategic guidance, and making decisions that align with Teva's Global Quality standards as well as regional and local regulatory requirements.
As a key business partner to the VP of APAC and the General Manager of ANZ, the CQA Lead collaborates across functions, thinks systemically, and resolves conflicts to ensure alignment between quality and commercial objectives. The incumbent drives results and generates solutions, while holding self and others accountable to foster a high-performing, quality-focused culture in support of Teva's Pivot to Growth strategy.
**How you'll spend your day**
+ Providing strategic quality oversight across the ANZ & APAC commercial portfolio.
+ Ensuring compliance with regulatory and Teva Global Quality Standards (GQS).
+ Leading, developing and mentoring a regional team of Quality professionals.
+ Managing product quality complaints, deviations, recalls, and investigations.
+ Acting as the primary quality contact for regional Health Authorities and licensing partners.
+ Driving risk assessment and mitigation strategies across markets.
+ Partnering cross-functionally with Commercial, Supply Chain, Regulatory Affairs, and Medical Affairs.
+ Leading quality integration efforts for new market entries, product launches, and portfolio transitions.
+ Representing APAC on global quality forums and initiatives.
+ Promoting continuous improvement and operational excellence.
**Your experience and qualifications**
+ Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science discipline (Master's degree preferred).
+ Extensive experience in pharmaceutical Quality Assurance, with a strong understanding of GMP/GDP/GVP.
+ Proven leadership in managing teams across diverse geographies and functions.
+ Strong knowledge of local and international regulatory requirements (e.g., TGA, FDA, EMA, PIC/S).
+ Demonstrated ability to influence and collaborate across a matrixed, global organisation.
+ Experience with audits, inspections, CAPAs, and quality systems management.
+ Excellent problem-solving, project management, and communication skills.
**Enjoy a more rewarding choice**
+ Generous leave, health, and wellbeing benefits
+ Commitment to ongoing personal & professional growth via a blend of learning opportunities
+ Opportunity to join a leading global organisation with a network of 37,000 employees operating in 60 markets, with 25 R&D sites
**Make a difference with Teva Pharmaceuticals**
Please submit your CV and Cover Letter to be considered.
Please note that only shortlisted candidates will be contacted.
**Reports To**
Vice President APAC Cluster Head & GM ANZ
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
EOE including disability/veteran
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Quality Assurance Associate

St Leonards, New South Wales Stryker

Posted 19 days ago

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**About the Role**
Join Stryker South Pacific's 2025 Team of the Year! Join a team where quality is less about policing and more about partnering!
As a Quality Assurance Associate, you'll play a pivotal role in ensuring our operations meet the highest standards of compliance and quality. You'll manage key quality management processes in alignment with international standards, Stryker Corporate policies, and regulatory requirements in Australia and New Zealand. This role is highly collaborative, partnering across departments-Sales, Marketing, Regulatory, Service, and Operations-to drive a quality-first mindset and ensure patient safety and regulatory excellence.
We currently have both permanent and maximum-term contract opportunities are are looking for our next superstar team members!
**About You**
You're a detail-oriented problem-solver with great attention to detail, curiosity and a strong ability to develop meaningful relationships quickly. You thrive in complex, layered environments, enjoy collaborative work, and have a knack for translating complex concepts into practical business processes. You're proactive, analytical, and committed to continuous improvement.
**Key Responsibilities**
+ Own and manage QMS processes in accordance with ISO 13485 and regulatory standards;
+ Act as a key contact for quality issues across SSP and global teams;
+ Represent Stryker in internal and external audits;
+ Lead and support Change Control, Nonconformances (NCs), and Corrective and Preventive Actions (CAPAs);
+ Train and coach SSP personnel on quality processes and regulatory obligations;
+ Maintain and update standard operating procedures and ensure compliant record keeping and documentation; and
+ Drive process improvement initiatives and stay informed on regulatory changes and educate
**Must Have Experience**
+ Working knowledge of regulatory frameworks and legislation in Australia and New Zealand;
+ Experience analyzing and interpreting regulatory documentation;
+ Strong time management and planning skills;
+ Effective communication and stakeholder engagement abilities;
+ Ability to build relationships across diverse team; and
+ Receptive to feedback and committed to personal growth.
**Nice to Have Experience**
+ Prior experience in regulatory affairs or quality assurance;
+ Experience in a regulated industry, ideally medical devices;
+ Familiarity with Australian and international medical device regulations; and
+ Tertiary qualifications in science, engineering, or a related field
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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Quality Assurance Technician

Alice Springs, Northern Territory KBR

Posted 23 days ago

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Title:
Quality Assurance Technician
Belong. Connect. Grow. with KBR!
KBR's National Security Solutions team provides high-end engineering and advanced technology solutions to our customers in the intelligence and national security communities. In this position, your work will have a profound impact on the country's most critical role - protecting our national security.
Why Join Us?
+ Innovative Projects: KBR's work is at the forefront of engineering, logistics, operations, science, program management, mission IT and cybersecurity solutions.
+ Collaborative Environment: Be part of a dynamic team that thrives on collaboration and innovation, fostering a supportive and intellectually stimulating workplace.
+ Impactful Work: Your contributions will be pivotal in designing and optimizing defense systems that ensure national security and shape the future of space defense.
This is a contingent position based upon contract award
Who We AreKBR Government Solutions delivers full life cycle professional and technical solutions that improve operational readiness and drive innovation. Our solutions help ensure mission success on land, air, sea, space and cyberspace for the Department of Defense, Intelligence Community, NASA and other federal agencies. KBR's areas of expertise include engineering, logistics, operations, science, program management, mission IT and cybersecurity. KBR strives to create a safer, more secure and sustainable world by bringing together the best and brightest to deliver technologies and solutions that help our customers accomplish their most critical missions and objectives.
The Mission AheadThis role is with KBR's Government Solutions U.S. division. At KBR Government Solutions, we don't just envision a world that's safer, more secure, and sustainable - we create it. Our legacy of delivering advanced full life cycle professional and technical solutions is matched only by our commitment to operational readiness and innovation. As stewards of critical missions for the Department of Defense, Intelligence Community, NASA, and other key federal entities, we excel in engineering, logistics, operations, science, program management, mission IT, and cybersecurity. United in our quest for excellence, KBR stands at the vanguard, ready to transform possibilities into impactful realities for a better tomorrow.
Who You AreYou're a detail-oriented and analytical Quality Assurance Technician with a strong ability to ensure products, services, and processes meet established standards of quality and reliability. With expertise in inspections, testing, and documentation, you excel at identifying and resolving issues to maintain compliance with regulatory and organizational requirements. Your knowledge of quality control procedures, attention to detail, and problem-solving skills ensure operational excellence.
At KBR, you bring a commitment to precision, thoroughness, and continuous improvement to every task. Known for your ability to work collaboratively and communicate effectively, you support teams in achieving quality benchmarks and driving mission success. Your dedication to upholding the highest standards aligns with KBR's mission of delivering innovative and reliable solutions for critical operations.
What You'll DoIn the role of Quality Assurance Technician, your duties will include:
+ Provides support in quality assurance (QA) tasks, collaborating with the QA team.
+ Assists in organizing and conducting quality training programs.
+ Participates in quality audits to assess compliance with established standards and identify areas for improvement.
+ Uses basic quality tools and principles to contribute to problem-solving efforts and assess the effectiveness of solutions.
+ Creates inspection reports to document work area conditions and ensure compliance with quality requirements.
+ Recommends corrective actions based on inspection findings to address deviations from standards.
+ Validates and verifies compliance with contractual quality standards.
+ Ensures alignment between the quality management function and performance needs.
+ Inspects materials received from vendors to ensure compliance with contractual requirements.
+ Documents nonconformities and assists in follow-up audits on corrective actions.
+ Supports inspections to ensure compliance with documented procedures/contract requirements.
+ Develops quality inspection checklists to facilitate inspection processes and ensure thoroughness.
Qualifications:
+ Must be a US or AUS Citizen
+ Must possess a US TS/SCI with Polygraph or AUS PV Clearance.
+ Must have a minimum of one year of quality experience.
+ Thorough knowledge of methodologies of quality assurance and standards.
+ Excellent numerical skills and understanding of data analysis/statistical methods.
+ Attention to Detail: Precision and attention to detail to ensure high-quality service delivery and compliance with safety standards.
+ Adaptability: Flexibility to adapt to changing conditions, technologies, and requirements.
+ Decision-Making Ability: Strong decision-making skills to resolve issues quickly and effectively under pressure
Desired Qualifications:
+ ASQ Certification or Australian Equivalent
#SF
Belong, Connect and Grow at KBRAt KBR, we are passionate about our people and our Zero Harm culture. These inform all that we do and are at the heart of our commitment to, and ongoing journey toward being a People First company. That commitment is central to our team of team's philosophy and fosters an environment where everyone can Belong, Connect and Grow. We Deliver - Together.
KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.
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Quality Assurance Manager

Truganina, Victoria Efficient Recruitment

Posted 3 days ago

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Position Title: Quality Assurance Manager
Company: M&A Cabinets br>Location: Truganina, VIC 3029
Salary: $76,000 – $85,000 AUD per annum < r>ANZSCO Code: 139916
About the Company
M&A Cabinets is a leading manufacturer and installer of high-quality custom cabinetry and joinery, proudly serving commercial and residential clients across Victoria. Known for precision craftsmanship and a commitment to excellence, we specialise in kitchens, wardrobes, vanities, and bespoke cabinet solutions tailored to each client's unique needs. With a growing customer base and a reputation built on trust, quality, and innovation, we are now seeking a dedicated Quality Assurance Manager to join our team and uphold the standards that define our brand.
About the Role
As the Quality Assurance Manager, you will play a key role in maintaining and enhancing the quality of our cabinet manufacturing processes, ensuring all products meet strict internal standards, client expectations, and regulatory requirements. You’ll lead quality control systems, ensure compliance with safety standards, and foster a culture of continuous improvement across our production operations. < r>Key Responsibilities
• Develop, implement, and oversee robust quality assurance frameworks across all stages of cabinetry design, production, and installation. < r>• stablish and monitor quality benchmarks to maintain consistency in product measurements, finishes, materials, and structural integrity. < r>• C nduct regular inspections and audits of raw materials, in-process components, and final products to ensure compliance with internal and Australian quality standards. < r>• L ad root cause analysis of product non-conformities and implement effective corrective and preventive actions. < r>• W rk closely with production teams to identify process improvements, enhance efficiency, and reduce rework or wastage. < r>• E sure workplace health and safety compliance in accordance with relevant legislation and industry guidelines. < r>• T ain and guide staff on quality control procedures, safe handling of materials, and best practices in cabinet assembly and installation. < r>• L aise with suppliers to ensure the consistency and reliability of materials supplied, addressing quality concerns as needed. < r>• M intain comprehensive documentation of quality control activities, inspection results, and compliance records. < r>• A alyze client feedback, warranty issues, and customer service trends to enhance product quality and satisfaction. < r>• P epare and present quality performance reports to senior management and support business goals through strategic quality initiatives. < r>• S ay updated on regulatory requirements, materials standards, and industry innovations to ensure continued excellence. < r>Skills & Qualifications
• B chelor’s degree in Engineering, Quality Management, Manufacturing, or a related discipline.
• S rong knowledge of QA systems, audit processes, and regulatory standards (e.g., ISO 9001, OH&S). < r>• E cellent communication, problem-solving, and leadership skills. < r>• H gh attention to detail, with the ability to work in a fast-paced and hands-on production environment. < r>• P oficient in using QA tools, software, and reporting systems. < r>Why Join M&A Cabinets?
• B part of a reputable and rapidly growing business in the manufacturing sector. < r>• W rk with a passionate team committed to excellence in design, construction, and installation. < r>• E joy a supportive and collaborative work environment with opportunities for career growth. < r>• C ntribute to delivering high-end products that shape interior spaces across Victoria.
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Assistant Quality Assurance Manager

Brisbane, Queensland KBR

Posted 23 days ago

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Job Description

Title:
Assistant Quality Assurance Manager
At KBR - We do things that matter.
We deliver science, technology and engineering solutions to governments and companies around the world. KBR employs approximately 38,000 people worldwide with customers in more than 80 countries and operations in over 29 countries.
KBR is proud to work with its customers across the globe to provide technology, value-added services, and long-term operations and maintenance services to ensure consistent delivery with predictable results. At KBR, We Deliver.
Think.KBR.com
KBR in Australia
With over 65 years working on some of Australia's largest and most complex projects, KBR has unmatched experience supporting the nation's critical infrastructure, energy transition and national security priorities. KBR has around 2,000 employees throughout Australia, who are focused on delivering innovative technology and engineering solutions for a safer, more secure and sustainable future.
Learn more about KBR in Australia
Belong, Connect and Grow at KBR
At KBR, we are passionate about our people and our Zero Harm culture. These inform all that we do and are at the heart of our commitment to, and ongoing journey toward being a People First company. That commitment is central to our team of team's philosophy and fosters an environment where everyone can Belong, Connect and Grow. We Deliver - Together.
The Opportunity:
Our client, a leading Managed Services Provider (MSP) supporting Defence capability, is seeking an Assistant Quality Manager with strong systems engineering experience to join a high-performing team on a Defence program in Brisbane. This position plays a key role in ensuring engineering processes, quality frameworks, and compliance obligations are met in line with Defence standards.
Reporting to the Quality Manager, you will support the assurance of engineering and technical deliverables, contributing to risk management, systems safety, and quality audits throughout the systems lifecycle. This role supports supply chain optimisation by conducting network studies, coordinating with stakeholders, and ensuring the timely delivery of goods and services. Through independent problem-solving and collaboration, the specialist contributes to the effective execution of logistics operations and supports continuous improvement initiatives across the organisation.
Responsibilities:
+ Support the development, implementation and continuous improvement of the Quality Management System (QMS) in accordance with ISO 9001 and AS9100 standards.
+ Ensure engineering processes align with Defence and MSP quality standards and customer requirements.
+ Conduct internal quality audits and support external audits (e.g., by CASG, primes, or other stakeholders).
+ Assist in systems safety and assurance tasks aligned with the One Defence Capability System (ODCS) and other acquisition frameworks.
+ Engage with multi-disciplinary engineering teams to embed quality into the design, development, and sustainment processes.
+ Participate in root cause analysis, risk reviews, and engineering change control procedures.
+ Maintain quality records and contribute to lessons-learned repositories.
+ Liaise with systems engineers and project managers to ensure compliance and traceability throughout the V&V lifecycle.
As the ideal candidate you will bring:
+ Engineering degree in Systems, Aerospace, Mechanical, Electrical, or related field.
+ Experience in Defence engineering environments and understanding of Defence capability lifecycle (ODCS).
+ Sound knowledge of quality management systems, assurance frameworks, and ISO/AS standards.
+ Strong background or exposure to Systems Engineering, particularly in requirements traceability, verification and validation (V&V), and interface management.
+ Exposure to systems safety and risk management principles (e.g. MIL-STD-882, T&E, hazard logs).
+ Proficiency in document control and configuration management tools (e.g. DOORS, Windchill, Teamcenter).
+ Strong communication and stakeholder engagement skills.
All candidates will be required to hold and maintain an active NV1 Defence Security Clearance. Only candidates holding a NV1 Clearance or above should apply.
What we will offer you:
· A workplace culture certified as a Great Place To Work
· Flexible working
· Competitive salary (including annual reviews)
· Paid parental leave
· Income protection
· Corporate rewards
· Salary packaging/Novated leasing
· Employee stock purchase plans
· Flu shots, skin checks and discounted private health insurance
· Career development: Online learning, mentorship and career pathways
If you're ready to shape tomorrow, let's get started. Apply Now!
As a Major Service Provider of the Australian Defence Force, an AGSVA security clearance will be required and compliance to International Traffic in Arms Regulations (ITAR). As such, our hiring decisions are based on the key requirements of each role and candidates are selected based on their unique strengths and experiences.
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Senior Manager - Quality Assurance Kite

Melbourne, Victoria Gilead Sciences, Inc.

Posted 4 days ago

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
At Gilead, we're committed to creating a healthier world for everyone - no matter the challenges ahead of us. For more than 30 years, we've pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we're driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It's what's next.
The Position:
We are seeking a highly experienced and motivated individual to join us as Associate Director or Senior Manager, Product and Distribution Quality in ANZ. You will work with Quality, Commercial, Regulatory, Supply Chain, and Medical Affair in supporting our efforts in this exciting area of cancer immunotherapy. This individual will work cross functionally to lead a multi-market organization focused on implementing and ensuring the qualification and monitoring program for hospital apheresis centers and treatment sites that will provide treatment to patients with our commercial products, investigations related to product complaints, the cross-functional work for global labeling capabilities, the full set of capabilities associated to Responsible Person (RP) in ANZ and other APAC region as needed, and representing QA in ANZ regional Leadership teams as well as representing Kite with external partners and others.
Key Responsibilities will include:
+ Establish, execute and manage the new and established apheresis centers and treatment centers sites (ACTS) qualification process that will use risk-based tools for qualification, training and monitoring.
+ With Global Site Qualification will determine strategy for maturing the ongoing program, sustainability and compliance to regulatory changes.
+ Collaborate with cross-functional departments to ensure timely implementation of quality processes.
+ Provide leadership and direction in the industry in the area of site qualification process and management.
+ Assess and approve any changes to the courier tracking and order intake systems to assure the validated state of the systems is maintained.
+ Lead Quality's collaboration efforts with Commercial in the start-up and routine management of the ATCS relationship and Supply Chain to ensure compliance across the Kite product Journey and best customer experience
+ Implement, assess and report on metrics monitoring per schedule and provide updates to approved ATC list.
+ Assure business systems are developed, supported and maintained validated state for patient traceability.
+ Act as Quality contact, or delegate, for ATCS issues and discrepancies, and lead/manage the investigations to resolve the issues.
+ Interacts with the Kite T cell Facilities as needed for product release, issue resolving or other as applicable
+ Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS-related matters.
+ Work with Global Site Qualification, America, EME and APAC regional leads , as needed.
+ Collaborate with our Gilead affiliates in the routine management of the ACTS relationships and in other areas as needed
+ Serve as Gilead RP per the local guidelines (TGA, HSA etc.). Act as back-up for RP in other APAC region as needed. Verify lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs and supervise quality/regulatory aspects of distribution in Australia and Singapore.
+ Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following QMS: distribution (under GDP), product complaints, recall, returns, self-inspection.
+ Provide oversight of deviation investigations which occur during the manufacturing, packaging and shipment of products and provide QA oversight and approval of Change Control records impacting Cell Therapy products in Australia, Singapore and other APAC region.
+ Maintain local Quality System to comply with local regulation.
+ Quality lead for Material Review Board for Cell Therapy Finished Products for Australia and Singapore
+ Perform other duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Knowledge, Experience and Skills Required:
+ Bachelor's degree in medical or biological sciences or related field; Master's or PhD degree preferred
+ Minimum of 7 years progressive experience in medical, pharmaceutical or biologics quality assurance' roles; preferred cell therapy.
+ Experience in areas such as Clinical Research, Medical Liaison, Cell Therapy and/or Apheresis and Cell Therapy Medical Centers preferred.
+ Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
+ Experience working in multi-national companies with management responsibilities of staff located in multiple regions/countries.
+ Proficiency in English is required
+ Strong working knowledge of and ability to apply GMP in conformance to ANZ.
+ Experience responding to regulatory agency audits.
+ Demonstrated ability to develop, coach, and mentor employees
+ Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
+ Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
+ Ability to travel up to 40%, could include some weekend travel for arrival to/return from destinations
**Gilead Core Values**
Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
**Being Here Matters**
_At Gilead we are committed, hardworking and passionate about improving the lives of the patients who use our products. Our values - integrity, inclusion, teamwork, accountability and excellence - are evident in everything we do. We are a close-knit team where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development._
_We want all our employees to embrace and leverage each other's talents and diverse perspectives, foster a sense of belonging, achieve their full career potential and contribute to the team's success.  This is demonstrated through our Silver Status in the Australian Workplace Equity Index. _
_As an equal opportunity employer, Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws._
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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Quality Assurance & Regulatory Affairs Associate

Sydney, New South Wales GN Hearing

Posted 23 days ago

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Job Description

Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
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