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