Associate Director, Clinical Quality Assurance
Centessa Pharmaceuticals•Boston, MA
•Onsite
About The Position
Centessa Pharmaceuticals, a clinical-stage company developing orexin receptor 2 (OX2R) agonists for sleep-wake disorders, is seeking an Associate Director, Clinical Quality Assurance (CQA). This role will oversee GCP-focused quality assurance for Centessa-sponsored clinical trials, ensuring compliance with global regulations, ICH guidelines, Centessa SOPs, and industry standards. The position involves leading daily clinical quality operations, maintaining quality programs and documentation, and ensuring GCP compliance and inspection readiness.
Requirements
- BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
- 8–10 years of experience in pharmaceutical quality roles.
- Experience with document control software (e.g., ZenQMS, Veeva Vault, MasterControl) required.
Responsibilities
- Lead and maintain GCP QA programs, policies, and procedures.
- Serve as primary GCP QA expert and point of contact.
- Ensure clinical programs comply with global health authority regulations and ICH guidelines.
- Provide QA oversight for protocols, ICFs, CSRs, and other trial documents.
- Monitor evolving GCP regulations and communicate impact to stakeholders.
- Develop and execute global GCP audit strategies and annual plans.
- Conduct and manage audits of investigator sites, CROs, suppliers, systems, and documents.
- Prepare audit reports, evaluate CAPAs, and ensure effective follow-up.
- Lead inspection readiness activities and support regulatory inspections (e.g., FDA, EMA, MHRA).
- Partner with cross-functional teams to ensure compliance.
- Represent CQA on study teams and contribute to protocol design and risk management.
- Collaborate on procedures, forms, and templates related to clinical quality.
- Identify compliance risks and implement mitigation strategies.
- Investigate quality issues, perform root cause analyses, and drive CAPA resolution.
- Prepare and present KPIs, metrics, and audit status updates to leadership.
- Develop and maintain GCP-related SOPs, training materials, and quality metrics.
- Lead process improvement initiatives across QA and broader organization.
- Provide mentorship and leadership to QA staff; may include direct management.
Benefits
- 401(k) plan
- company-sponsored medical, dental, vision, and life insurance
- generous paid time off
- health and wellness program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
