Associate Director, QA (R&D)
About The Position
Reporting to the Director, Quality Assurance, the Associate Director, R&D Quality Assurance is responsible for managing early-stage contract drug product manufacturers, contract packagers, contract testing labs, contract raw material manufacturers and contract warehouses from a supplier quality perspective. This position is responsible for review and approval of investigations for production deviations and laboratory OOS; review and approval of change controls for master manufacturing records and test methods; test method validation protocols and reports; drug product, API and label specifications; review of master and executed batch records; and product disposition. This position also supports vendor management, supplier audits and quality agreements.
Requirements
- Bachelor’s Degree plus 12+ years experience in the Pharmaceutical Industry
- 7+ years experience in Pharmaceutical Quality Assurance
- Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
- Strong attention to detail
- Proficient technical skills across multiple platforms
- Strong knowledge of Microsoft Office Systems
- Analytical skills to interpret statistical data
Responsibilities
- Attend Project Team Meetings; collaboration with Pharmaceutical Sciences and Program Management
- Participate in vendor calls
- Review and approve Vendor Change Controls
- Review and approve vendor documents including Master Manufacturing Records and Master Packaging/Labeling Records
- Review and approve all specifications
- Review/Approve Deviations/OOS
- Review/Approve Test Record Form/Certificate of Analysis
- Review executed manufacturing batch records and packaging/labeling batch records
- Review/Complete Batch Record Review Form
- Complete Final Disposition Form and issue Certificate of Compliance
- Author/Revise Quality Assurance Procedures
- Review and Approve Pharmaceutical Sciences SOPs
- Perform audit report review of audits performed by 3rd party auditors
- Attend Supplier Audits, as needed
- Review proposed Quality Agreements
Benefits
- health, dental and vision insurance benefits
- generous paid time off, including vacation, holidays, and personal days
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What This Job Offers
Job Type
Full-time
Career Level
Director
