Quality Director

Moorabbin, Victoria PCI Pharma Services

Posted 9 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 of Services - Imaging, ANZ

Hawthorn, Victoria GE HealthCare

Posted 9 days ago

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Job Description

**Job Description Summary**
The Director of Services - Imaging, ANZ, leads field service operations across Australia and New Zealand for GE HealthCare's Imaging portfolio, driving service excellence, operational efficiency, and customer satisfaction. This role oversees a high-performing team of service managers and engineers, ensuring safe, compliant, and timely service delivery. With a focus on continuous improvement, workforce development, and customer-first strategies, the leader supports Imaging business growth through strategic leadership and cross-functional collaboration.
This role reports into the Services General Manager, Australia & New Zealand
**Job Description**
**Key responsibilities include (but are not limited to):**
**LEADERSHIP**
+ Sets the vision and operational tactics to develop a world leading Field Operations team, across the various Imaging modalities.
+ As an integral part of ANZ Services Leadership team, leads and participate in local, regional & global initiatives and projects over and above the as needed or required to help drive speed, teamwork and quality for our customers and front-line teams.
+ Ensure the highest standards of safety for employees and customers.
+ Actively seek out market and customer drivers to ensure the business adapts quickly and capitalises on shifting trends in Service delivery.
+ Enables managers and leaders within the Imaging Field Operations teams to coach, manage, mentor and influence individuals and teams directly or indirectly reporting to this role, to drive overall accountability, ownership and progress against goals.
+ Ensure the Imaging Field Operations team has the right talent, roles and operational structures in place to lead, coach and develop a team of Service Managers, Region Support Engineers and Field Engineers to deliver outstanding customer experience in ANZ
+ Create operating mechanisms to ensure the right metrics are in place which reflect the health of the business and ensure an operating rhythm is in place with the Service Delivery Managers to review exceptions and address outliers in a timely manner.
+ Lead with a Lean mindset to improve key processes, for our colleague and customer experience
+ Collaborate with peers in the Service Organisation, Functional teams and Sales Leadership teams to drive and execute on key business priorities and drive a customer first approach to resolving issues.
**CUSTOMER SUPPORT**
+ Drive and develop financial, operational and customer-based metrics which demonstrate the health of the Field Operations delivery model in supporting our customers and financial commitments to the business.
+ Implement processes to provide remote, as well as on-site support to customers via the Field Engineering teams. Ensure teams are adequately trained to deliver these services and work with Region Support Engineers, On-line Engineers and Modality Engineers to formulate a robust plan for the ANZ Imaging business
+ Manage professional relations with key customers, academia government & administrative bodies to deepen understanding of customer challenges and needs. Nurture relationship with professional society stakeholders within geographical area
+ Work with the Customer Service Center (CSC) and the On-Line Engineering (OLE) teams to create virtual and seamless remote support processes
+ Work with Technical Service Solutions Leader to drive detailed investigations and actions for customer hot sites and continually implement process changes to improve first fix rates
+ Work with supporting teams such as CSC, Logistics, Project Management (PMO), Applications, Sales, Product Specialists to ensure processes are in place to manage successful and timely hand-offs between teams and customer experience is seamless and positive.
+ Lead the collaboration with Sales team on customer communication, escalations and key opportunities
+ Supporting the commercial activities for key accounts by providing account-based feedback via the Field teams which assist GEHC to better meet the needs of customers.
+ Provide Technical input, budget and resource preparation for new product launches including Field engineering education and training to ensure readiness in field for NPI's.
+ Support tender submissions as required.
**OPERATIONS RIGOUR**
+ Work with the ANZ EHS leader to ensure all field activity is conducted to the highest standards and further develop our safety culture.
+ Drive processes for timely field escalations - Customer satisfaction opportunities (CSO), Quality, Product Quality (PQM), Part returns, FOA. Lead the region by ensuring representation from a technical and field standpoint for any global / regional calls related to quality / CSO's
+ Drive adherence to field processes such as parts ordering & return, Service Request (SR) rigour, primary FE/site alignment, On Call control, Overtime control, Tools & Test Equip compliance etc.
+ Lead initiatives to improve overall speed & quality of response to customers
+ Lead Field Modification instructions (FMI) execution for Imaging Field Operations
+ Drive processes to complete customer obligations in a timely manner Preventative Maintenance (PMs/ePMs, etc.) adhering to the mandatory quality and compliance procedures
+ Work with PMO on installations and ensure timely delivery of system to customers
+ Implement new tools and processes as required to drive speed and efficiency
+ Participate in overall operating mechanisms and metrics with the view to drive operational rigour in the organisation, spanning all areas of the operation including but not limited to field efficiency, customer satisfaction, productivity, back office efficiency, financials and quality.
**TALENT DEVELOPMENT, TRAINING & WORKFORCE PLANNING**
+ Working with Training Specialists, Global Training Centres and Technical Operations team, develop a wholistic competency & training plan for the Imaging Field Operations teams. Identify technical and non technical training and/or competency gaps and put in place a training plan by modality/geography to improve field coverage.
+ Work with Technical Operations, Regional Support Engineers and the Field Service Operations teams to set up and operationalize channel partners as required.
+ Conduct & lead regular People Reviews of team and ensure development plans are in place for SDM, SFE and RSE roles. Actively work with our HR partners to strengthen and develop the talent for the Imaging business
+ Develop an approach in supporting the Imaging install base through resourcing the region effectively to drives profitability and efficiency.
+ Develop and lead appropriate operating mechanisms to ensure performance of function is optimised and reported appropriately.
+ Regularly provides updates, including regular communication to the business via various written, recorded, live presentations / updates to ensure visibility of the function across -ANZ.
**QUALITY, SAFETY & COMPLIANCE**
+ Create and drive a culture of safety and compliance in the Imaging Field Service Operations team
+ Drive safety metrics to ensure processes are followed always
+ Partner with QA, RA, Product, PMO and Service teams to drive:
+ Install and Site Readiness checklists
+ Radiation and Electrical licensing
+ Electrical Safety compliance
+ FMI process execution
+ SR Quality (CHU)
+ Tools & Test Equip calibration and compliance
**Quality Specific Goals:**
+ Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
+ Complete all planned Quality & Compliance training within the defined deadlines
+ Identify and report any quality or compliance concerns and take immediate corrective action as required
+ Knowledge and understanding of all Global Privacy and Anti-Competition Policies (including but not limited to GE Healthcare HIPPA Guidelines, NEMA Regulations, etc.) and operates within them to ensure that no company policy or US / Int'l Law is broken.
+ Knowledge and understanding of all Environmental Health Policies (including but not limited to GE Healthcare EHS Policies, GE Healthcare Fleet Rules, etc.) and operate within them to ensure that no company policy or US / Int'l Law is broken
+ Ownership of order and configuration quality at the point of entry to ensure accuracy, configuration integrity and that all requirements are tied to documented customer inputs.
+ Drive continuous improvement on all related processes, work instructions, and procedures to ensure ongoing standardization and simplification of the Quality Management System.
+ Responsible for 100% compliance on teams EHS goals and metrics.
**Qualifications and Preferred Experience:**
+ Bachelor's degree or equivalent experience in technical, healthcare, or business disciplines.
+ Minimum 10 years of technical, commercial, or operational leadership experience.
+ At least 5 years leading multi-functional teams across a broad geographic area.
+ Demonstrated experience applying Lean or Six Sigma in a service environment.
+ Advanced understanding of service operations, customer experience, and commercial strategy
+ Strong understanding of business metrics and financial acumen.
+ Proven experience leading leaders (e.g., managing managers or senior technical teams).
+ Strong track record of developing talent and building high-performing teams.
+ Demonstrated success driving transformation or change initiatives in a complex service environment.
+ Experience working in a matrixed, global organization with cross-functional collaboration.
+ Regular travel across ANZ is required.
The role is ideally placed in Sydney but Melbourne or Brisbane may be considered as suitable locations for a base of this candidate.
**Additional Information**
**Relocation Assistance Provided:** No
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