Associate Director / Director, Clinical Quality Assurance

beamtherapeutics· Quality
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📍 Cambridge, MA

About this role

Company Overview:

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.

Position Overview:

Beam is seeking an experienced Clinical Quality professional at the Associate Director / Director level to join our grown Quality Team.  Reporting to the Senior Director, Clinical Quality Assurance, this role will provide strategic and operational leadership for inspection readiness, program quality oversight, and vendor oversight as Beam advances toward its first regulatory submission and potential associated inspections.

Responsibilities:

  • Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans.
  • Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities.
  • Support health authority inspections, including document review, response coordination, and follow-up remediation activities.
  • Serve as the Clinical QA Lead for assigned studies and programs.
  • Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents.
  • Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits.
  • Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation.
  • Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group. Support TMF migration activities, as required.
  • Lead quality investigations, root cause analysis, and CAPA development.
  • Partner with Clinical Development, Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory Affairs to provide compliance and inspection readiness support.
  • Coach cross-functional teams on GCP R3 expectations.
  • Contribute to the continued evolution of the Quality Management System, including oversight and trending of key quality metrics (internal and external).
  • Support clinical and QA SOP development efforts.

Qualifications:

  • University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry. Experience in a clinical stage biotech company preferred.
  • 10+ years of relevant experience in clinical/GCP quality. Level will be commensurate with experience.
  • Outstanding expertise in GCP R3 and solid understanding of PV regulations.
  • Demonstrated ability to successfully partner cross-functionally.
  • Excellent interpersonal effectiveness, including exceptional communication skills.
  • Advanced computer skills, including experience working in Veeva.
  • Consistent excellent judgement and pragmatic, risk-based decision making skills.
  • Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range
$185,000—$260,000 USD

Frequently Asked Questions

Is the salary disclosed for the Associate Director / Director, Clinical Quality Assurance position at beamtherapeutics?
The salary for this Associate Director / Director, Clinical Quality Assurance role at beamtherapeutics is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Associate Director / Director, Clinical Quality Assurance position at beamtherapeutics located?
This Associate Director / Director, Clinical Quality Assurance role at beamtherapeutics is based in Cambridge, MA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Which team or department does the Associate Director / Director, Clinical Quality Assurance at beamtherapeutics belong to?
This Associate Director / Director, Clinical Quality Assurance position is part of the Quality department at beamtherapeutics. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Associate Director / Director, Clinical Quality Assurance position at beamtherapeutics?
Click the "Apply Now" button on this page. You will be redirected to beamtherapeutics's official application portal hosted on greenhouse where you can submit your application directly.
When was the Associate Director / Director, Clinical Quality Assurance job at beamtherapeutics posted?
This Associate Director / Director, Clinical Quality Assurance position at beamtherapeutics was posted on Jun 9, 2026. Apply as soon as possible — early applications are often reviewed first.
Associate Director / Director, Clinical Quality Assurance
beamtherapeutics
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