Beam Therapeutics

Associate Director / Director, Clinical Quality Assurance

Cambridge, MA · Director · Full-time

Sponsorship not specified$185k-$260kDetected 43 days ago

GCPFDA RegulatoryCRISPRLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs

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.
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.

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans.
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.
Lead quality investigations, root cause analysis, and CAPA development.
Support clinical and QA SOP development efforts.

10+ years of relevant experience in clinical/GCP quality.
Outstanding expertise in GCP R3 and solid understanding of PV regulations.
Support TMF migration activities, as required.
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.
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

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry.
Experience in a clinical stage biotech company preferred.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting.

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.
Support health authority inspections, including document review, response coordination, and follow-up remediation activities.
Partner with Clinical Development, Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory Affairs to provide compliance and inspection readiness support.

This listing is sourced directly from Beam Therapeutics's careers page and normalized into a canonical job model.