Senior Manager / Associate Director, Clinical Quality Assurance

Responsibilities

• Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP service providers supporting clinical development.
• Maintain a risk-based vendor qualification and oversight framework, including qualification assessments, audits, periodic re-assessments and documentation of vendor quality status.
• Partner with study team members to ensure appropriate quality oversight of associated vendors.
• Determine overall audit strategy / schedule for external GCP/GCLP/GVP vendors, including which audits to conduct internally vs outsource.
• Support QA leadership for significant vendor quality issues, including investigations, RCA, CAPA development/assessment, and effectiveness.
• Support the development of and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits.
• Support execution of enterprise-wide GCP inspection readiness strategies and plans.
• Partner cross-functionally to promote effective sponsor oversight of outsourced activities consistent with ICH E6 R3 expectations.
• 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 as requested.
• Contribute to the continued evolution of the Quality Management System, including oversight and trending of key quality metrics (internal and external).
• Support clinical and QA SOP development efforts.
• Ensure adherence to GxP requirements and SOPs.
• Embody Beam’s cultural values and align daily actions with departmental goals and company culture.

Qualifications

• University degree in a scientific discipline/life sciences.
• Experience in a clinical stage biotech company preferred.
• 7+ years of relevant experience in clinical/GCP quality. Level will be commensurate with experience.
• 3+ years of experience conducting or managing GCP vendor and investigator site audits.
• Professional audit certification (e.g., ASQ CQA, RQAP-GCP) preferred.
• 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.