Senior Director of GMP QA - Sacramento California

Company: VirtualVocations
Location: Sacramento, California
Posted On: 02/04/2025

A company is looking for a Senior Director, GMP QA to lead the GMP QA strategy and execution for its portfolio.



Key Responsibilities

Develop and oversee the global GMP QA strategy for the company's portfolio
Provide leadership and mentorship to the quality system team and collaborate on CMC-related quality activities
Monitor vendor performance and ensure compliance with regulatory requirements through audits and batch record reviews



Required Qualifications

Bachelor's or Master's degree in Life Sciences, Engineering, or a related scientific discipline
Over 15 years of experience in quality assurance roles within the pharmaceutical industry
In-depth knowledge of cGMP regulations and experience with batch record reviews and QA release of clinical trial materials
Proven track record of managing quality activities at CDMOs and developing GMP audit programs
Strong leadership skills with the ability to collaborate and influence stakeholders effectively More...

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