Senior Level Associate Director Clinical Quality Assurance Jobs
Senior level associate director clinical quality assurance jobs place experienced professionals in charge of GCP compliance strategy, audit programs, and the clinical operations teams that execute them. Roles are concentrated across Biotechnology & Pharmaceuticals and Healthcare & Medical Services, with a mix of on-site, hybrid, and remote openings, and employers like Revolution Medicines, Systimmune, and Beam Therapeutics hiring at this level now.
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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.
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.
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Senior Level Associate Director Clinical Quality Assurance Jobs: Frequently Asked Questions
How do I get a senior level associate director clinical quality assurance job?
Employers at this level look for candidates who have owned end-to-end quality systems, led inspection readiness programs, and managed cross-functional teams through regulatory submissions or audits. Demonstrated experience driving CAPA resolution, authoring SOPs, and influencing stakeholders outside QA gives candidates a clear edge. A history of building or restructuring QA functions signals the leadership maturity these roles require.
Which companies hire senior level associate director clinical quality assurances?
Companies hiring senior level associate director clinical quality assurances right now include Revolution Medicines, Systimmune, and Beam Therapeutics, based on current listings on Migrate Mate as of October 2026. Hiring at this level comes primarily from mid-size to large pharmaceutical, biotechnology, and contract research organizations that operate regulated clinical development programs and require seasoned QA leadership.
Are there remote senior level associate director clinical quality assurance jobs?
Yes, though availability varies by organization and therapeutic focus. About 14% of senior level associate director clinical quality assurance openings are remote or hybrid as of October 2026, reflecting broader flexibility in QA leadership roles that center on oversight and strategy rather than hands-on site work. Fully on-site positions remain common at larger sponsor companies and CROs with established quality operations.
What makes an associate director clinical quality assurance role senior level?
Senior level roles carry program-wide or functional ownership rather than task execution. Expectations include setting quality strategy across multiple studies or therapeutic areas, leading audits independently, mentoring junior QA staff, and representing quality in cross-functional governance forums. The distinction from mid-level roles is accountability for outcomes, not just activities, and the ability to influence regulatory and operational decisions without close supervision.
Which industries hire the most senior level associate director clinical quality assurances?
Senior level associate director clinical quality assurance roles concentrate in Biotechnology & Pharmaceuticals and Healthcare & Medical Services, based on current listings on Migrate Mate as of October 2026. These sectors drive hiring because they operate active clinical pipelines under FDA and ICH GCP oversight, requiring experienced QA leaders who can scale compliance infrastructure alongside rapidly evolving trial portfolios.