Senior Manager / Associate Director, Clinical Quality Assurance

Beam Therapeutics Inc.; Cambridge (MA); Vor Ort; USD 155.000 - 225.000; Vollzeit

Zusammenfassung

Beam Therapeutics Inc. in Cambridge, MA seeks an experienced Senior Manager / Associate Director of Clinical Quality Assurance to lead vendor qualification and ongoing oversight for CROs and clinical service providers, ensuring GCP compliance across studies.

This role partners cross-functionally to implement risk-based QA programs and drive inspection readiness. The ideal candidate has 7+ years in clinical/GCP quality, CRO/audit management experience, and strong knowledge of FDA/EMA/ICH

Qualifikationen

• 7+ years of clinical/GCP quality experience in a biotech or pharma setting.
• Experience qualifying and overseeing CROs and external vendors.
• Strong knowledge of FDA, EMA, MHRA and ICH guidelines.

Aufgaben

• Lead qualification and ongoing quality oversight of CROs and GCP/GCLP/GVP providers.
• Maintain risk-based vendor qualification and oversight framework with audits.
• Collaborate with study teams to ensure vendor quality oversight.
• Define audit strategy for external vendors and investigations with CAPA follow-up.
• Support enterprise-wide GCP inspection readiness and QA program evolution.

Kenntnisse

GCP quality

Vendor/Audit management

CRO oversight

Quality systems

Veeva experience

Ausbildung

Bachelor's degree in life sciences

Tools

Veeva

Jobbeschreibung

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:

The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership for the qualification and ongoing quality oversight of CROs and other clinical service providers while providing clinical quality support for assigned studies. This role will partner cross-functionally to implement risk-based vendor oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams. This position will also support quality investigations, audits, CAPAs, and inspection readiness activities to ensure effective sponsor oversight and sustained clinical trial compliance.

Responsibilities:

• Lead and manage the qualification and ongoing quality oversight of CROs and other GCP/GCLP/GVP service providers supporting clinical development.
• Maintain a risk-based vendor qualification and oversight framework, including qualification assessments, audits, periodic re-assessments and documentation of vendor quality status.
• Partner with study team members to ensure appropriate quality oversight of associated vendors.
• Determine overall audit strategy / schedule for external GCP/GCLP/GVP vendors, including which audits to conduct internally vs outsource.
• Support QA leadership for significant vendor quality issues, including investigations, RCA, CAPA development/assessment, and effectiveness.
• Support the development of and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits.
• Support execution of enterprise-wide GCP inspection readiness strategies and plans.
• Partner cross-functionally to promote effective sponsor oversight of outsourced activities consistent with ICH E6 R3 expectations.
• Serve as the Clinical QA Support for assigned studies and programs.
• Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents as requested.
• 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.
• Ensure adherence to GxP requirements and SOPs.
• Embody Beam’s cultural values and align daily actions with departmental goals and company culture.

Qualifications:

• University degree in a scientific discipline/life sciences.
• Experience in a clinical stage biotech company preferred.
• 7+ years of relevant experience in clinical/GCP quality. Level will be commensurate with experience.
• 3+ years of experience conducting or managing GCP vendor and investigator site audits.
• Professional audit certification (e.g., ASQ CQA, RQAP-GCP) preferred.
• Direct experience qualifying and overseeing CROs and other service providers.
• Strong knowledge of GCP and applicable FDA, EMA, MHRA and ICH requirements.
• Demonstration 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.
• 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.

Beam Pay Range:

$155,000 — $225,000 USD