Manager, Quality Operations

Job Summary

Responsible for leading day-to-day quality oversight of manufacturing and operational activities to ensure compliance with cGMP, regulatory requirements, and company quality systems. Drives execution, inspection readiness, and continuous improvement across quality operations.

Responsibilities

• Daily GMP Oversight (Shop Floor + Operations), providing real-time QA oversight of manufacturing and packaging activities of a multi-site, multi-shift operation.
• Manage the product quality release program, ensuring on-time results and adherence to internal procedures.
• Provide quality risk assessment and decision support real-time, including containment correction measures.
• Review and release of batch records.
• Author, review and/or approve quality documentation related to manufacturing.
• Ensure adherence to SOPs, batch records, and GMP requirements.
• Lead and/or oversee deviations, OOS, complaints, and investigations, ensuring robust root cause analysis and effective CAPAs.
• Manage Quality Operations personnel, setting priorities, staffing plans and shift coverage.
• Manage incoming materials quality review/approval to ensure materials are appropriately received, assessed, and released for use in accordance with applicable procedures.
• Coach team on GMP decision-making, risk-based quality judgement and investigator rigor.
• Monitor and report key quality metrics, including right first time.
• Identify trends and drive process improvements and simplification.
• Ensure continuous state of audit readiness, supporting health authority inspections and internal audits.
• Act as a primary QA partner to Manufacturing, Quality Control and Supply Chain and Quality Systems.

Qualifications

• Education: Bachelor’s degree (Science, Engineering, or related)
• Experience: ~7-10 years in GMP pharmaceutical manufacturing QA/QC
• Leadership: Prior people management or strong informal leadership
• Expertise: cGMP regulations (FDA / EU), Quality systems (CAPA, deviations, change control), Manufacturing and/or QC operations
• Computer skills: Excellent computer skills required (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio).
• Project management skills: Strong project management skills, strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and on budget.
• Business acumen: Strong business acumen surrounding pharmaceutical manufacturing.
• Travel: Some travel required.