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Senior Manager / Associate Director, Clinical Quality Assurance

Beam Therapeutics · Cambridge, MA · On-site

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About Beam Therapeutics

Backed by GV.

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. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • BS in a scientific discipline/life sciences
  • Experience in a clinical stage biotech company preferred
  • Typically 8+ years of relevant experience in clinical/GCP quality with 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
More about this 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. 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.

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...

Read the full posting on Beam Therapeutics's site ↗

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