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.

Associate Director, Quality Control at Beamtherapeutics | JobZoey