Senior Manager, GMP Quality – Remote | 6-Month Contract

Job ID: 37609761

Sigma Systems is seeking an experienced Senior Manager, GMP Quality for a 6-month remote contract opportunity. This position is ideal for a senior-level pharmaceutical or biotechnology Quality professional with strong GMP, batch release, CMO management, quality systems, investigations, CAPA, change control, and validation experience.

Job Title: Senior Manager, GMP Quality

Job Type: Contract
Contract Duration: 6 Months
Work Arrangement: 100% Remote
Industry: Pharmaceutical / Biotechnology / Life Sciences
Experience: 8+ Years
Education: Bachelor’s Degree in a Scientific or Relevant Discipline

Position Overview

The Senior Manager, GMP Quality will serve as a key Quality representative across cross-functional teams and will work closely with internal Quality, Manufacturing, CMC, Supply Chain, Commercial Manufacturing teams, and external contract manufacturing organizations (CMOs). The role will support product release, technical transfers, validation, quality events, investigations, CAPA, change controls, complaints, and GMP quality systems.

Key Responsibilities

• Serve as the QA representative on cross-functional project teams.
• Partner with Quality and Production teams at domestic and international contract manufacturing organizations (CMOs).
• Conduct product release activities for clinical and commercial drug substances and drug products.
• Review and approve Master Batch Records and Executed Batch Records.
• Review release and stability documentation and perform final batch disposition.
• Partner with CMC and Commercial Manufacturing teams on technical transfers and process/product validation.
• Review and approve validation protocols and reports.
• Ensure compliance with GMP procedures while identifying opportunities to improve quality systems, processes, and workflows.
• Author, review, and approve SOPs, procedures, and electronic quality systems.
• Lead or support quality events, investigations, CAPA, change controls, and complaints.
• Work directly with domestic and international suppliers and external partners to resolve complex quality issues.
• Serve as Person-in-the-Plant (PIP) when required.
• Contribute to Annual Product Reviews (APRs) by compiling data, analyzing metrics, and developing recommendations.
• Apply formal risk management tools and assessments to evaluate technically complex quality events.
• Support continuous improvement and ensure GMP quality systems remain aligned with evolving regulatory and industry standards.
• Communicate effectively with senior management, project teams, internal stakeholders, and external partners.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Pharmacy, or another relevant scientific discipline.
• 8+ years of relevant experience in the pharmaceutical, biotechnology, or life sciences industry.
• Strong professional background in Quality Assurance / GMP Quality.
• Advanced knowledge of GMP manufacturing and/or pharmaceutical market release.
• Experience with pharmaceutical dosage forms and/or combination products.
• Proven experience managing external CMOs, contract laboratories, and third-party logistics providers.
• Hands-on experience reviewing and approving Master Batch Records and Executed Batch Records.
• Experience performing final disposition of drug substances and finished drug products.
• Strong knowledge of investigations, CAPA, change controls, complaints, and quality events.
• Working knowledge of formal quality risk management tools and assessments.
• Demonstrated ability to evaluate technically complex GMP quality issues.
• Excellent technical writing, documentation, and communication skills.
• Experience developing and improving GMP quality systems, policies, SOPs, and compliance procedures.
• Strong analytical and problem-solving skills with the ability to develop practical recommendations and action plans.
• Ability to work independently, prioritize multiple assignments, and operate effectively in a fast-paced environment.

Preferred Candidate Profile

The ideal candidate is a senior GMP Quality professional who has worked extensively within pharmaceutical or biotechnology manufacturing environments and can independently manage complex Quality activities. Candidates with strong experience in batch record review, product disposition, CMO oversight, quality investigations, CAPA, change control, validation, technical transfers, and GMP quality systems are encouraged to apply.