Senior QA Manager — GMP Oversight & CMO Lead

Katalyst-Healthcares-; Port Reading (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

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

Skills

GMP Quality

Sponsor oversight

QA Oversight

Regulatory Submissions

Inspection Readiness

CMC Collaboration

Education

Bachelor's degree in science

Job description

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.