Senior Manager / Associate Director, Clinical Quality Assurance

The role

The Senior Manager / Associate Director of Clinical Quality Assurance provides leadership for the qualification and quality oversight of CROs and clinical service providers. This role partners cross-functionally to implement risk-based vendor oversight and provides GCP guidance to study teams.

What you will do

• Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP service providers.
• Maintain a risk-based vendor qualification and oversight framework.
• Partner with study team members to ensure appropriate quality oversight of associated vendors.
• Determine overall audit strategy and schedule for external GCP/GCLP/GVP vendors.
• Support QA leadership for significant vendor quality issues, including investigations, RCA, and CAPA.
• Support development and execution of program/study-level risk-based audit plans.
• Support execution of enterprise-wide GCP inspection readiness strategies and plans.
• Partner cross-functionally to promote effective sponsor oversight of outsourced activities.
• Serve as the Clinical QA Support for assigned studies and programs.
• Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents.

Required qualifications

• BS in a scientific discipline/life sciences.
• 8+ years of relevant experience in clinical/GCP quality.
• 3+ years of experience conducting or managing GCP vendor and investigator site audits.
• Direct experience qualifying and overseeing CROs and other service providers.
• Strong knowledge of GCP and applicable FDA, EMA, MHRA and ICH requirements.
• Demonstration ability to successfully partner cross-functionally.
• Excellent interpersonal effectiveness, including exceptional communication skills.
• Advanced computer skills, including experience working in Veeva.
• Consistent excellent judgement and pragmatic, risk-based decision making skills.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

Nice to have

• Experience in a clinical stage biotech company preferred.
• Professional audit certification (e.g., ASQ CQA, RQAP-GCP) preferred.

About the company

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. The company uses base editing technology to advance a diversified portfolio of base editing programs.