Associate Director, QA (R&D)

About the Role

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.

Let’s talk about some of the key responsibilities of the role:

Quality Assurance 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

 Vendor Management Responsibilities

• Perform audit report review of audits performed by 3rd party auditors
• Attend Supplier Audits, as needed
• Review proposed Quality Agreements

Factors for Success:

• 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 Preferred

A Few Other Details Worth Mentioning:

• The position is hybrid and will be based in our beautiful Irvine office three days per week, complete with a courtyard, snacks, drinks, occasional catered meals, and pet-days.
• This position reports directly to the Director, Quality Assurance
• Some travel may be required – up to 15%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $150,000 - $210,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

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