Associate Director, R&D Quality Assurance (Early-Stage Development)

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
• Lead and oversee QA activities for early Phase (preclinical through phase I/II) clinical development programs.
• Develop, implement and maintain Quality Management systems (QMS) to support early development activities.
• Ensure compliance with global GxP regulation, (GCP, GLP, GMP) in addition to Tarsus’ internal policies and industry standards.
• Provide strategic QA input to cross functional teams, Including Clinical development, Regulatory Affairs, Analytical development, Supply chain and CMC
• Serve as QA representative on development project team and advise on risk mitigation strategies
• Contribute to the writing, review and approval of SOPs, protocols reports and regulatory submissions
• Process and approve change controls, deviations within Tarsus’ QMS system
• Review and approve CMO’s master batch records, analytical documents and validation protocols
• Review executed batch records and disposition batches (CTM) per Tarsus’ internal policies
• Participating in CMO and Tarsus’ operation meetings
• Provide support for two/three arms blinded studies
• Participate in vendor calls

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
• Experience in early-phase clinical development and a sound understanding of the drug development life cycle

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.
• This position reports directly to the Director, Quality Assurance
• This position may require traveling up to 15% of time

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.

#LI-Hybrid