Senior GMP Quality Manager

Katalyst CRO; United States; Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Katalyst CRO is seeking a senior QA professional to lead sponsor-side QA oversight across pre-clinical, clinical, and commercial manufacturing stages, including drug substance, drug product, and final product. You will own quality oversight for commercial-stage activities and collaborate with CMC, Supply Chain, and Analytical Development to ensure compliant, inspect-ready operations.

You will also review deviations, CAPAs, change controls, and documentation, support regulatory submissions

Qualifications

• Bachelor's degree in a scientific or technical discipline
• 8+ years GMP Quality experience in pharma, including late-stage drug product development and validation
• Sponsor-side CMO oversight experience clinical-stage across DS/DP/FP, or commercial-stage specifically on drug substance
• Experience with process validation (PPQ) and late-stage/commercial regulatory submissions
• Inspection readiness experience (domestic and/or ex-US) preferred

Responsabilités

• Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing drug substance, drug product, and final product
• Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
• Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
• Review and approve CMO documentation, batch records, and test data; perform product dispositions
• Support quality review of regulatory submissions (IND/IMPD, NDA) and participate in inspection readiness
• Represent QA cross-functionally with CMC, Supply Chain, and Analytical Development
• Maintain quality metrics and periodically revise GMP SOPs

Connaissances

GMP QA experience

CMO oversight experience

Process validation (PPQ)

Regulatory submissions

Inspection readiness

Formation

Bachelor's degree in a scientific or technical discipline

Description du poste

Responsibilities

• Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing drug substance, drug product, and final product
• Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
• Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
• Review and approve CMO documentation, batch records, and test data; perform product dispositions
• Support quality review of regulatory submissions (IND/IMPD, NDA) and participate in inspection readiness
• Represent QA cross-functionally with CMC, Supply Chain, and Analytical Development
• Maintain quality metrics and periodically revise GMP SOPs

Key Responsibilities

• Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing drug substance, drug product, and final product
• Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
• Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
• Review and approve CMO documentation, batch records, and test data; perform product dispositions
• Support quality review of regulatory submissions (IND/IMPD, NDA) and participate in inspection readiness
• Represent QA cross-functionally with CMC, Supply Chain, and Analytical Development
• Maintain quality metrics and periodically revise GMP SOPs

Qualifications

• Bachelor's degree in a scientific or technical discipline
• 8+ years GMP Quality experience in pharma, including late-stage drug product development and validation
• Sponsor-side CMO oversight experience clinical-stage across DS/DP/FP, or commercial-stage specifically on drug substance
• Experience with process validation (PPQ) and late-stage/commercial regulatory submissions
• Inspection readiness experience (domestic and/or ex-US) preferred