Senior Specialist, Quality Operations

Catalent is a leading global CDMO, trusted by pharma, biotech, and self‑care companies to accelerate the development, manufacturing, and delivery of products that improve lives.

As Senior Specialist, Quality Operations at our U.S. Cell Therapy manufacturing facility in Princeton, NJ, you will provide advanced QA oversight, lead the development and management of Quality Systems, ensure regulatory compliance, support audits and inspections, and act as the dedicated Client QA representative.

The role involves overseeing quality advanced oversight and guidance for all programs in support of GMP manufacturing of cell therapy products, leading the development and management of Quality Systems, ensuring compliance with regulations, supporting audits and inspections, and driving continuous improvement.

• Monday – Friday, 8:00 am – 5:00 pm.
• 100% on‑site.

• 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.

• Bachelor of Science degree required (preferably in a Life Sciences discipline);
  Master of Science preferred.
• Minimum of 7 years’ experience within the biologic, biopharmaceutical, or regulated industry.
• Experience performing cGMP internal audits and/or supplier audits; auditor certification (CQA or equivalent) a plus.
• Cross‑site, inter‑ and intra‑departmental project‑management experience, and experience with electronic document management systems desired.
• Proficiency in GMP regulations, batch record review, and batch disposition processes, with ability to apply scientific and regulatory principles.
• 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.
• Proficiency 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.

Salary: $110,000 – $125,000 (New Jersey) plus annual bonus, when eligible. The final salary offered may vary based on experience, education, and business needs.

• 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 401(k) benefits effective day one of employment.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email Disabili and include the job number, title, and location.