Senior Specialist, Quality Operations

Catalent

1d • Onsite

About The Position

Catalent is a leading global CDMO that partners with pharma, biotech, and self-care companies. Their U.S. commercial cell therapy manufacturing facility in Princeton, NJ, is part of Catalent’s cell therapy network and is equipped with 16 flexible clean rooms, QC labs, and warehouse space. The Senior Specialist, Quality Operations provides advanced Quality oversight and guidance for all programs supporting GMP Manufacturing of Cell Therapy products at this facility. This role involves leading the development and management of Quality Systems, ensuring regulatory compliance, and supporting audits and inspections. The specialist will also serve as the dedicated Client QA Representative, collaborating with cross-functional teams like Manufacturing, Process Development, and Technology Transfer to maintain site compliance and drive continuous improvement. This position reports to the Director, Quality.

Requirements

• Bachelor of Science degree required, preferably in a Life Sciences discipline.
• Minimum of 7 years’ experience within the biologic, biopharmaceutical, or regulated industry.
• Experience performing cGMP internal audits and/or supplier audits.
• Proficient in GMP regulations, batch record review, and batch disposition processes, with ability to apply scientific and regulatory principles to resolve operational and quality challenges.
• Experience with Risk Management and Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Proficient with biological manufacturing processes including cell banking, microbial/cell culture, fermentation, purification, and fill/finish.
• Strong communication skills (verbal, written, oral), proven ability to work independently and collaboratively, prioritize tasks, and apply problem-solving skills in a fast-paced GMP environment.

Nice To Haves

• Master of Science degree preferred.
• Auditor certification (CQA or equivalent) is a plus.
• Cross-site, inter and intra departmental project management experience and experience with electronic document management systems desired.

Responsibilities

• Provide advanced QA oversight for GMP documentation, batch record review, and compliance activities.
• Lead development and management of Quality Systems, including change control, risk management, and supplier qualification.
• Support and manage investigations (OOS, deviations), CAPAs, and engineering change requests.
• Review and approve validation protocols, COAs/COCs, calibration, and maintenance records for completeness.
• Compile, track, and present quality metrics for batch release, client projects, and site compliance programs.
• Drive process improvements to reduce defects, improve turnaround times, and ensure timely batch disposition.
• Serve as dedicated QA liaison for client projects from initiation through closure, including audits and meetings.
• Coordinate and facilitate risk assessments, maintain site risk register, and report to leadership.
• Author, review, and revise SOPs; conduct internal audits; and support external audits and inspections.
• Train new QA staff and contribute to Management Reviews and Annual Product Reviews.
• Other duties as assigned.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior