About the Role

Reporting to the Vice-President of Quality, the Associate Director of Quality Assurance is responsible for managing 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; process 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

• Participate in Vendor calls
• Review and approve VCCs (Vendor Change Controls)
• Review and approve vendor documents including Master Batch Records/Master Packaging 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 batch records
• Review/Complete Batch Record Review Form
• Complete Final Disposition Form and Certificate of Compliance
• Author Annual Product Reviews
• Author/Revise Quality Assurance Procedures
• Review and Approve QC, Pharmaceutical Sciences and Technical Operations SOPs
• Initiate Product Complaint investigations, interface with the call center and assure investigations are properly conducted
• Trend analysis of data; generate charts and graphs

Vendor Management Responsibilities

• Perform audit report review of audits performed by 3rd party auditors
• Perform GMP audits as needed and author reports for audits performed
• Review proposed Quality Agreements

Factors for Success:

• 10 years experience in the Pharmaceutical Industry
• 7 years experience in Pharmaceutical Quality Assurance
• Bachelor's Degree from accredited university
• Attention to detail
• Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
• Strong computer skills
• Knowledge of Microsoft Office Systems
• Experience with statistical analysis of data
• ASQ Certification 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, table tennis, snacks and drinks, occasional catered meals, and pet-days. Remote work two days per week.
• This position reports directly to the Vice-President of Quality

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 $138,700 - $194,300 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://alliantbenefits.cld.bz/Tarsus2023BenSnapshot.

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