Senior Director, Quality Assurance

3 days ago

Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time
Job Title: Senior Director, Quality Control

Beam Therapeutics Inc. is seeking a highly experienced Senior Director, Quality Control to join our team in Cambridge, Massachusetts. As a key member of our Quality Control organization, you will be responsible for leading the quality control organization at our Massachusetts facility and providing strategic direction to our Quality Control teams.

Key Responsibilities:
  • Provide overall CMC Quality Control leadership across multiple programs and cross-functional forums.
  • Develop and execute QC strategies for method qualification, transfer, and validation in partnership with Analytical Development and other key roles.
  • Provide strategic direction to the Cambridge-based Quality Control team(s) performing internal QC testing.
  • Interact with Beam's suppliers (e.g., CMOs/CTLs) in a QC leadership capacity, as well as Beam's internal manufacturing site in RTP, NC.
  • Develop overall monitoring and measures for method/testing aspects: in-process, release, stability testing, OOT/OOS results.
  • Coordinate with Quality Assurance to ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them.
  • Coordinate with Quality Assurance to ensure Quality Agreements are complete, approved, and updated at appropriate intervals.
  • Responsible for ensuring cGMP principles are implemented and adhered to within internal and supporting external laboratories.
  • Ensure quality control systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
  • Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
  • Ensures continuous improvement across the Quality Control Group.
Qualifications:
  • BS or Advanced degree in a scientific discipline.
  • 15+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development, and/or quality. Strong preference for direct experience with cell and/or gene therapy programs.
  • Experience in leading teams associated with elements of Quality and Quality Control as part of overall background is preferred.
  • Experience supporting all phases of a program's lifecycle (pre-IND through commercial lifecycle management).
  • 10+ years of Quality management experience.
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions.
  • Experience interacting with regulatory health authorities at pre- and post-approval inspection.
  • Solid knowledge of global regulations and standards.
  • 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.
  • Excellent team building, leadership, and management skills.
  • Excellent listening, communication, and interpersonal skills fostering team spirit.
  • Consistent delivery of high-quality work at all times.
  • Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.
Location:

This is a hybrid role, however, this role requires that the candidate(s) live within a reasonable commuting distance to be on site in our Cambridge location several times per week.

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