Associate Director, Quality Control
Associate Director, Quality Control
Jazz Pharmaceuticals
Dublin, Ireland
Responsibilities
The Associate Director, Quality Control is responsible for Jazz quality control (QC) activities in support of commercial operations for drug substances, APIs and drug product, ensuring compliance with regulatory requirements and international GMP/quality standards. Through collaborations with CMO partners the individual in this role ensures that QC support is provided to commercial objectives including product supply, process improvements and ensures successful outcomes in regulatory filings and inspections. Furthermore, Associate Director of QC ensures that appropriate oversight and direction of analytical activities at contract laboratories (CTL) and contract manufacturing operations (CMO).
Essential Accountabilities
- Lead quality control activities at contract laboratories and contract manufacturing operations.
- Ensure required QC support to maintain product supply in alignment with product team goals and objectives
- Provide QC support to ensure successful outcomes in regulatory filings, communications, meetings, and inspections.
- Ensure compliance with regulatory, GMP and quality standards.
- Ensure management of laboratory investigations, change controls, CAPAs and commitments in a compliant manner.
- Management of Stability programs in collaboration with CMO's
- Collaborate with external partners to ensure Jazz QC requirements are fully represented across the global organization
- Collaboration with internal stakeholders including Global Technical Operations and Supply Chain, QA, and Regulatory Affairs to ensure business objectives are delivered
- Actively lead QC continuous improvement opportunities
- Active participation in the Quality Management Team to support external manufacturing activities
Key Responsibilities
Direct responsibility for QC management/oversight of the following areas:
- Management of Jazz commercial contract test/development laboratories and associated QTA's
- Management and qualification of reference standards associated with Jazz APIs and drug products
- Leading OOS/OOT investigations in partnership with CMOs ensuring closure in compliant manner
- Jazz lead for managing compendia updates on all commercial products
- Management of specifications for raw materials, components, drug substances, APIs and drug products
- Stability data review and statistical analysis lead for Jazz products
- Lead for analytical method transfers/validation programs
- Lead for analytical method troubleshooting and support with CMO
- Perform audits at Contract Test Laboratories and CMOs
- Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company specific GMP activities.
- Collaborate with regulatory affairs to support regulatory submissions and response letters as directed.
- Highlight any risks associated with maintaining supply of commercial drug products and develop effective mitigations
- Staff management if required
- Ability to travel up to 20%
Qualifications and experience
- BSc, MSc or PhD in chemistry, biochemistry, pharmaceutical science, or related field. 8-10 years progressive experience from individual contributor to manager/supervisor of quality control (or related analytical development, pharmaceutical development, or manufacturing) function.
- Demonstrated experience in Regulatory Authority interactions (filings, inspections).
- Experience of managing diverse laboratories (including contract laboratories) at different geographic locations.
- Analytical experience with diverse range of product formulations is desirable
- Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution.
Other Skills, Personal Competencies
- Superior communications skills (written and oral).
- Ability to tolerate ambiguity
- Patient and results focused
- Strong communication skills
- Facilitate creative and innovative solutions
- Project management.
- Working in multi-disciplinary, multi-site, multi-cultural/international teams. Strategic planning.
- Financial management.
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