Senior Quality Manager, GMP

Katalyst-Healthcares-; Port Reading (NJ); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC seeks an experienced QA professional to lead sponsor-side oversight of GMP quality across pre-clinical to commercial manufacturing. The role focuses on DS/DP/FP, including process validation (PPQ) and product disposition, with responsibility for deviations, CAPAs, change controls, and documentation revisions.

You will review batch records and test data, support regulatory submissions (IND/IMPD, NDA), and participate in inspection readiness while aligning QA with

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• 8+ years GMP Quality experience in pharma.
• 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 Quality

Sponsor oversight

QA Oversight

Regulatory Submissions

Inspection Readiness

CMC Collaboration

Formation

Bachelor's degree in science

Description du poste

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.