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Associate Director / Director, Clinical Quality Assurance
- Cambridge, Massachusetts, United States
- Cambridge, Massachusetts, United States
Über
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
Sprachkenntnisse
- English
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