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
#J-18808-Ljbffr
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
#J-18808-Ljbffr