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