Beamtherapeutics
Associate Director, Quality Control
Cambridge, MA. Posted 2 months ago
The role
The Associate Director will lead the Massachusetts Quality Control team in delivering compliant GMP testing. This role supports clinical and late-stage programs while transitioning the group toward commercial operations.
What you will do
- Lead the Massachusetts QC organization to ensure timely and compliant GMP testing.
- Provide leadership and oversight for QC staff performing routine testing and data review.
- Ensure the QC laboratory remains in a continuous state of inspection readiness.
- Own or oversee QC quality-system records including deviations, investigations, and CAPAs.
- Partner with Data Integrity and Quality Systems to ensure GMP data meet ALCOA+ principles.
- Maintain analytical method and laboratory readiness.
- Ensure QC testing operations support clinical manufacturing and commercial readiness.
- Use quality metrics and audit observations to drive continuous improvement.
- Provide leadership for laboratory issue resolution and escalation.
- Coach and develop QC staff through individual development plans and succession planning.
Required qualifications
- Advanced degree, or equivalent experience, in Chemistry, Biochemistry, Molecular Biology, Cell Biology, Analytical Sciences, Pharmaceutical Sciences, or a related scientific discipline.
- 10+ years of experience.
- 8+ years of relevant industry experience in Quality Control within biologics, cell therapy, gene therapy, mRNA, or other complex therapeutic modalities.
- Prior experience leading or managing a GMP Quality Control laboratory team.
- Strong understanding of GMP laboratory operations.
- Demonstrated experience with quality systems, including deviations, investigations, change controls, and CAPAs.
- Working knowledge of data integrity expectations and ALCOA+ principles.
- Experience supporting regulatory inspections, mock inspections, or internal audits.
- Demonstrated ability to lead cross-functional issue resolution.
- Strong technical judgment and problem-solving skills.
- Ability to manage competing priorities.
- Excellent written and verbal communication skills.
About the company
Beam Therapeutics is a biotechnology company with an integrated platform for precision genetic medicines using base editing technology. The organization is committed to providing life-long cures to patients suffering from serious diseases.