Beam Therapeutics
Senior Manager / Associate Director, Clinical Quality Assurance
Cambridge, MA · Director · Full-time
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DOL prevailing wage, 2026-27 wage year · Software Quality Assurance Analysts and Testers (15-1253) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- 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.
- 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.
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.
- 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.
- Support clinical and QA SOP development efforts.
Requirements
- Typically 8+ years of relevant experience in clinical/GCP quality with 3+ years of experience conducting or managing GCP vendor and investigator site audits.
- Strong knowledge of GCP and applicable FDA, EMA, MHRA and ICH requirements.
- BS in a scientific discipline/life sciences.
- Direct experience qualifying and overseeing CROs and other service providers.
- 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.
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
- Beam Pay Range
Nice to have
- Experience in a clinical stage biotech company preferred.
- Professional audit certification (e.g., ASQ CQA, RQAP-GCP) preferred.
Compensation
- The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.
Visa & Work Authorization
- sition will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance
This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.