Director/Sr. Director of CMC Quality Assurance
EPM Scientific, New York, NY, United States
Director / Senior Director, CMC Quality Assurance
Manhattan, NY (Onsite, 5 days/week)
Clinical‑Stage Biotech
Full-Time | High‑Impact Individual Contributor
A rapidly growing clinical‑stage biotech is seeking a Director / Senior Director of CMC Quality Assurance to lead QA activities across drug substance, drug product, analytical, labeling, packaging, and clinical supply operations. This is a hands‑on, high‑ownership role supporting multiple small‑molecule development programs.
The ideal candidate brings deep experience in small‑molecule CMC , GMP clinical manufacturing , and external manufacturing oversight , with the ability to implement phase‑appropriate quality systems in a fast‑moving environment.
Key Responsibilities
CMC QA Oversight
- Provide QA leadership across drug substance (DS) and drug product (DP) manufacturing
- Review and approve batch records, release packages, stability documentation, and analytical results
- Serve as QA approver for clinical batch disposition
- Support IMP manufacturing, packaging, labeling, and distribution
Quality Systems & Compliance
- Lead QA activities for deviations, OOS/OOT, investigations, change controls, and CAPAs
- Build, refine, and implement phase‑appropriate eQMS / QMS processes
- Drive inspection readiness for FDA and global regulatory authorities
External Partner Oversight
- Act as QA point of contact for CDMOs, CROs, testing labs, and packaging/distribution vendors
- Lead and support domestic and international audits
- Negotiate, maintain, and enforce Quality Agreements
- Ensure compliance of external partners with GMP and regulatory expectations
CMC Regulatory Support
- Partner with Regulatory CMC on IND, IMPD, Module 3 content
- Review CMC submissions, stability justifications, analytical method reports, and control strategies
- Support responses to regulatory authority questions
Cross-Functional Collaboration
- Work closely with CMC, Technical Operations, Analytical Development, Supply Chain, and Clinical Operations
- Support tech transfer, validation, and manufacturing readiness activities
- Provide QA guidance during development milestones and clinical supply planning
Qualifications
- Bachelor's, Master's, or PhD in Chemistry, Pharmaceutical Sciences, or related discipline
- 10+ years of experience in pharmaceutical CMC QA, with strong preference for small‑molecule development
- Hands‑on experience with clinical batch release , labeling/packaging QA , and CDMO oversight
- Strong understanding of analytical method validation/transfer and stability programs
- Demonstrated success supporting regulatory submissions (IND/IMPD/NDA/MAA)
- Experience implementing or enhancing eQMS/QMS in a development‑stage environment
- Ability to work onsite 5 days/week in Manhattan (required)
- Excels as an individual contributor in a lean, fast‑paced biotech setting