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