Associate Director, GCP QA – Clinical Trials

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

Health and wellness program

Job summary

Centessa Pharmaceuticals is seeking an Associate Director, Clinical Quality Assurance to oversee GCP QA for Centessa-sponsored trials across Early to Late Phase, ensuring compliance with global regulations and ICH guidelines. The role leads daily clinical quality operations and maintains robust QA programs and documentation.

This position will provide QA oversight for trial documents, monitor evolving regulations, and partner with cross-functional teams to ensure compliance and inspection

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8–10 years of pharmaceutical quality experience.
• Experience with document control software (ZenQMS, Veeva Vault, MasterControl).

Responsibilities

• Lead and maintain GCP QA programs, policies, and procedures.
• Serve as primary GCP QA expert and point of contact.
• Ensure programs comply with global regulations and ICH guidelines.
• Provide QA oversight for protocols, ICFs, CSRs, and trial documents.
• Develop and execute global GCP audit strategies and plans.
• Lead audit activities of sites, CROs, systems, and suppliers.

Skills

GCP compliance

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Education

BS or higher in Life Sciences, Chemistry, Pharmacy, or related field

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Centessa Pharmaceuticals is seeking an Associate Director, Clinical Quality Assurance to oversee GCP QA for Centessa-sponsored trials across Early to Late Phase, ensuring compliance with global regulations and ICH guidelines. The role leads daily clinical quality operations and maintains robust QA programs and documentation.

This position will provide QA oversight for trial documents, monitor evolving regulations, and partner with cross-functional teams to ensure compliance and inspection