Senior Manager / Associate Director, Clinical Quality Assurance
Beam Therapeutics
Beam Therapeutics seeks a Senior Manager/Associate Director of Clinical Quality Assurance to lead vendor qualification and oversight for clinical service providers, manage audit strategies, and provide quality support across clinical development programs in Cambridge, MA.
Responsibilities
- Lead qualification and ongoing quality oversight of CROs and GCP/GCLP/GVP service providers
- Develop and maintain risk-based vendor qualification framework with assessments and re-assessments
- Determine audit strategy and schedule for external vendors; conduct or outsource audits as appropriate
- Support quality investigations, root cause analysis, CAPA development and FDA inspection readiness
- Provide clinical QA support for assigned studies including protocol and regulatory document reviews
Requirements
- University degree in scientific or life sciences discipline
- 7+ years clinical or GCP quality assurance experience
- 3+ years conducting or managing GCP vendor and investigator site audits
- Professional audit certification such as ASQ CQA or RQAP-GCP preferred
- Direct experience qualifying and overseeing CROs and clinical service providers
- Clinical stage biotech company experience preferred
Vacancy posted 9 days ago
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