Clinical Quality Assurance

Company Overview:

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview:

The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership for the qualification and ongoing quality oversight of CROs and other clinical service providers while providing clinical quality support for assigned studies.  This role will partner cross-functionally to implement risk-based vendor oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams.  This position will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance.

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.