Senior GMP Quality Manager

JobDiva, Inc.; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Fives DyAG Corp. is seeking a Senior QA Lead to oversee sponsor-side quality systems for CMOs spanning pre-clinical through commercial drug substance and product releases.

The role emphasizes GMP compliance, process validation (PPQ), and regulatory submissions support, with cross-functional collaboration across CMC, Supply Chain, and Analytical Development. It offers a challenging environment for driving inspection readiness and continuous quality improvement.

Qualifications

• Bachelor's degree in a scientific or technical field.
• 8+ years GMP Quality experience in pharma.
• Sponsor-side CMO oversight experience.
• Experience with process validation (PPQ) and late-stage/commercial regulatory submissions.
• Inspection readiness experience 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 QA experience

Education

Bachelor's degree in scientific/technical discipline

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