Manager Quality Assurance Operations

Catalent seeks a Manager of Quality Assurance Operations to provide on-the-floor QA oversight for GMP cell therapy manufacturing at its Princeton, New Jersey facility. The role involves batch record review, lot disposition, deviation management, and direct support of aseptic and cell processing operations, reporting to the Director of Quality.

Responsibilities

• Provide real-time QA on-the-floor support for cell therapy manufacturing including aseptic processing and cryopreservation
• Review executed batch production records, logbooks, and GMP documentation for accuracy and regulatory compliance
• Review and approve raw materials, consumables, and critical reagents used in cell therapy processing
• Review, assess, and approve deviations, nonconformances, investigations, and change controls impacting operations
• Support inspection readiness, regulatory inspections, and client audits while providing cross-functional leadership

Requirements

• Bachelor's degree in Science, Engineering, or related discipline
• Minimum 7 years GMP-regulated pharmaceutical, biologics, or cell/gene therapy manufacturing experience
• Minimum 3 years leadership or supervisory experience with demonstrated coaching ability
• 5+ years Quality Assurance experience with direct on-the-floor manufacturing support
• Strong knowledge of 21 CFR Parts 210/211, biologics regulations, EU GMPs, and ICH guidelines
• Cell therapy, ATMP, or aseptic processing experience strongly preferred
• Strong written and verbal English communication with ability to manage multiple priorities

Compensation: $130,000-$160,000 base plus annual bonus