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Senior GCP QA Leader Regulatory Readiness

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Cogent Biosciences
Full Time position
Listed on 2026-07-23
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
Salary/Wage Range or Industry Benchmark: 180000 - 205000 USD Yearly USD 180000.00 205000.00 YEAR
Job Description & How to Apply Below
Position: Senior GCP QA Leader for Regulatory Readiness

Cogent Biosciences is seeking an Associate Director, Quality Assurance GCP to provide strategic leadership over GCP quality activities across clinical development. This role ensures compliance with regulatory requirements and SOPs, while partnering with Clinical Development, Regulatory Affairs, Data Management, and external vendors to maintain inspection readiness.

The ideal candidate has 8-10 years in GCP QA, deep knowledge of FDA/EMA/ICH-GCP guidelines, and strong communication skills to

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Position Requirements
10+ Years work experience
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