Manager, GMP Quality Operations

Role Summary

Manager, GMP Quality Operations

Responsibilities

• Serve as QA floor presence during manufacturing operations to provide real-time guidance, issue resolution, and batch record review.
• Ensure production activities are executed in compliance with cGMP, aseptic technique, and company SOPs.
• Support review and approval of batch records, logbooks, deviations, CAPAs, and change controls.
• Partner with cross-functional teams to ensure manufacturing suites, cleanrooms, and critical utilities remain in qualified state.
• Provide QA oversight of equipment qualification, calibration, and preventative maintenance programs.
• Review and approve environmental monitoring data, investigate excursions, and ensure timely resolution of facility, manufacturing and QC related deviations.
• Oversee compliance with aseptic process simulations (APS), gowning qualifications, and cleaning/disinfection programs.
• Ensure raw material release processes meet requirements, including supplier quality documentation and risk assessments.
• Participate in audit and inspection readiness activities; host and support regulatory inspections as QA representative.
• Champion a culture of quality and continuous improvement.

Qualifications

• 6+ years of experience in GMP Quality Assurance or Operations. Experienced candidates may be considered at the senior manager level.
• Bachelor‚Äôs degree in a scientific or engineering discipline (or equivalent experience).
• Prior pharmaceutical experience required. Cell therapy manufacturing experience a plus.
• Strong understanding of FDA, EMA, and ICH regulations for biologics/cell therapy manufacturing.
• Demonstrated ability to build strong relationships, resolve complex issues, and influence cross-functional stakeholders.
• Effective organization and prioritization skills, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.