Associate Director, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance

Location: Rockville, MD (on-site)

EPM Scientific is partnered with an innovative, clinical‑stage biotechnology company to hire an Associate Director of Clinical Quality Assurance. Our client is seeking a hands‑on quality leader to own and evolve the Clinical QMS while supporting late‑stage development and commercialization readiness, including preparation for a BLA approval inspection. This role will play a critical part in shaping GCP quality strategy, driving inspection readiness, and ensuring alignment across Clinical Operations, Regulatory, and external partners. If you're looking for a high‑visibility opportunity where you can build, influence, and grow within a fast‑moving environment, this could be a strong next step.

Key responsibilities:

• Lead implementation and continuous improvement of the Clinical Quality Management System (QMS), including change control, deviations, complaints, audits, and vendor management
• Drive execution of the GCP quality strategy across clinical programs
• Ensure inspection readiness and serve as a lead during regulatory inspections and vendor audits
• Oversee quality risk management activities and drive risk‑based decision making
• Review and approve clinical and quality documentation (protocols, deviations, CAPAs, change controls, etc.)
• Own development and maintenance of Clinical SOPs and training programs
• Manage clinical quality systems, including document control and training platforms
• Partner with Clinical Operations, Regulatory, and Data Management to ensure compliance and alignment
• Provide regular updates to senior leadership on quality performance and inspection readiness
• Build, coach, and lead a high‑performing Clinical Quality team
• Support budgeting, resource planning, and vendor management

Background requirements:

• Bachelor's degree in a scientific discipline
• 10+ years of biopharmaceutical industry experience, with a strong focus in Clinical Quality
• 6+ years of leadership experience in Clinical QA
• Deep experience with GCP, FDA, and ICH regulations and guidelines
• Proven track record supporting regulatory inspections, including BLA/pre‑approval inspections
• Strong experience building and maintaining Quality Management Systems
• Familiarity with complex or advanced therapies (e.g., cell and gene therapy) is a plus
• Strong leadership, communication, and organizational skills
• Ability to operate independently while maintaining objective quality oversight