Senior Director, GxP QA
Senior Director, GxP QA
Location: Greater Boston (Hybrid)
Overview
EPM Scientific is partnered with a clinical-stage biotechnology company to hire a Senior Director, GxP QA. Our client is seeking a highly independent quality systems leader to oversee GxP systems, vendor management, and computer system validation activities across the organization. This is a high-visibility individual contributor role with direct exposure to executive leadership and significant influence across Quality, Clinical, Technical Operations, and Research functions. The position is ideal for someone who enjoys building scalable systems, driving compliance, and helping prepare an organization for commercialization.
Key Responsibilities
- Own and oversee GxP systems across Quality, Clinical, Technical Operations, and Research functions
- Lead vendor qualification, risk assessment, auditing, and ongoing oversight activities
- Manage all computer system validation (CSV) activities, including validation planning, execution, periodic reviews, and revalidation efforts
- Ensure compliance with 21 CFR Part 11 and applicable regulatory requirements
- Support cross-functional teams by maintaining data integrity and compliant systems to support development and regulatory milestones
- Deliver GxP systems training and drive continuous improvement initiatives across the organization
- Monitor system performance, identify trends, and implement process improvements
- Oversee document management activities to ensure records remain organized, compliant, and inspection-ready
- Partner with stakeholders across Quality, Clinical, CMC, Regulatory, and Research to support business objectives and inspection readiness
Requirements
- Bachelor's degree in Life Sciences or a related technical discipline
- 10+ years of Quality Assurance experience within biotech or pharmaceutical environments
- Strong experience managing GxP systems, vendor oversight, audits, and computer system validation activities
- Expertise with eQMS, EDMS, training systems, and other regulated platforms
- Experience in clinical-stage or clinical/commercial biotechnology environments
- Strong knowledge of FDA, ICH, and 21 CFR Part 11 requirements
- Ability to work independently and effectively in a fast-paced, evolving organization
- Must be authorized to work in the U.S. without sponsorship
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