Manager Quality Assurance Operations

About the role

The Manager, Quality Assurance Operations – Cell Therapy provides on-the-floor Quality Assurance (QA) oversight for GMP cell therapy manufacturing operations. This role ensures compliant execution, review, and disposition of manufacturing activities, materials, and documentation associated with clinical and commercial cell therapy products.

Responsibilities

• Provide real-time QA on-the-floor support for cell therapy manufacturing operations, including aseptic processing, cell handling, cryopreservation, fill/finish, and material handling activities.
• Perform GMP walkthroughs and observe critical manufacturing steps to ensure compliance with approved procedures, batch records, and Good Documentation Practices (GDP).
• Support manufacturing personnel during execution of complex or high-risk operations to ensure quality, compliance, and right-first-time execution.
• Review executed batch production records, logbooks, and associated GMP documentation for accuracy, completeness, and regulatory compliance.
• Support timely batch record review and participate in lot disposition and release decisions for clinical and commercial products.
• Review, assess, and approve deviations, nonconformances, investigations, CAPAs, and change controls impacting manufacturing operations, facilities, equipment, or materials.
• Support supplier qualification activities, material-related investigations, and ensure material qualification documentation meets internal and regulatory requirements.
• Support inspection readiness activities and participate in regulatory inspections and client audits to ensure adherence to the Catalent Quality Management System (QMS), site SOPs, and global standards.
• Provide day-to-day leadership and QA guidance while collaborating cross-functionally with Manufacturing, Supply Chain, MS&T, Validation, and Regulatory Affairs, and supporting QA Operations training and development.

Requirements

• Bachelor’s degree in Science, Engineering, or related discipline required; advanced degree preferred.
• Minimum of 7 years of experience in a GMP-regulated pharmaceutical, biologics, or cell/gene therapy manufacturing environment.
• Minimum of 3 years of prior leadership or supervisory experience required, with demonstrated ability to coach and manage performance.
• 5+ years of Quality Assurance experience supporting manufacturing operations; direct QA on-the-floor experience required.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• Demonstrated experience supporting GMP operations, including batch record review, lot disposition, deviation investigations, change control, and work performed in manufacturing and cleanroom environments.
• Strong knowledge of GMP regulations and guidance, including 21 CFR Parts 210/211, 600-series (biologics), applicable EU GMPs, and ICH guidelines; cell therapy, ATMP, or aseptic processing experience strongly preferred.
• Experience with raw material qualification and release activities; supplier quality experience preferred.
• Strong written and verbal communication skills in English, with the ability to work cross-functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

Qualifications

• Bachelor’s degree in Science, Engineering, or related discipline required; advanced degree preferred.
• Minimum of 7 years of experience in a GMP-regulated pharmaceutical, biologics, or cell/gene therapy manufacturing environment.
• Minimum of 3 years of prior leadership or supervisory experience required, with demonstrated ability to coach and manage performance.
• 5+ years of Quality Assurance experience supporting manufacturing operations; direct QA on-the-floor experience required.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• Demonstrated experience supporting GMP operations, including batch record review, lot disposition, deviation investigations, change control, and work performed in manufacturing and cleanroom environments.
• Strong knowledge of GMP regulations and guidance, including 21 CFR Parts 210/211, 600-series (biologics), applicable EU GMPs, and ICH guidelines; cell therapy, ATMP, or aseptic processing experience strongly preferred.
• Experience with raw material qualification and release activities; supplier quality experience preferred.
• Strong written and verbal communication skills in English, with the ability to work cross-functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

Skills

• Strong knowledge of GMP regulations and guidance, including 21 CFR Parts 210/211, 600-series (biologics), applicable EU GMPs, and ICH guidelines; cell therapy, ATMP, or aseptic processing experience strongly preferred.
• Experience with raw material qualification and release activities; supplier quality experience preferred.
• Strong written and verbal communication skills in English, with the ability to work cross-functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).

Benefits

Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
Potential for career growth on an expanding team.
Cross-functional exposure to other areas within the organization.
152 hours of paid time off annually + 8 paid holidays.
Medical, dental, vision and 401K benefits effective day one of employment.
Tuition Reimbursement.

Pay

The anticipated salary range for this position in New Jersey is $130,000 - $160,000 plus annual bonus, when eligible.

Schedule

Work Schedule: Monday – Friday, 8:00am-5:00pm.