Senior Specialist, Quality Operations

Catalent

Princeton, NJ, US
Base: $110,000 - $125,000; bonus/equity: annual bo...
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7 years biologic or biopharmaceutical experience
Bachelor of science in life sciences
Proficiency in cgmp regulations and batch disposition
** Catalent is seeking a Senior Specialist in Quality Operations for its Princeton, NJ facility, focused on supporting GMP manufacturing of cell therapy products. The ideal candidate will have extensive experience in quality oversight, regulatory compliance, and project management within the biologic or biopharmaceutical industries. **

Job Summary

  • The Senior Specialist provides advanced Quality oversight for GMP documentation and batch record review to support cell therapy manufacturing at the Princeton facility.
  • Candidates will serve as the dedicated Client QA Representative, partnering with cross-functional teams to maintain site compliance and drive continuous improvement.
  • The role offers a competitive salary range of $110,000 - $125,000 plus annual bonus, along with comprehensive benefits including 152 hours of paid time off.

Matching Summary

Match Score: 75

** Catalent is seeking a Senior Specialist in Quality Operations for its Princeton, NJ facility, focused on supporting GMP manufacturing of cell therapy products. The ideal candidate will have extensive experience in quality oversight, regulatory compliance, and project management within the biologic or biopharmaceutical industries. **

Salary

Base: $110,000 - $125,000; Bonus/Equity: Annual bonus when eligible; Benefits: Medical, dental, vision, 401K, 152 PTO hours + 8 holidays

Skills & Requirements

Must-have

  • 7 years biologic or biopharmaceutical experience
  • Bachelor of Science in Life Sciences
  • Proficiency in cGMP regulations and batch disposition
  • Experience with internal and supplier audits
  • Knowledge of 21 CFR Parts 210, 211, and 600s

Nice-to-have

  • Master of Science degree preferred
  • Auditor certification (CQA) is a plus
  • Electronic document management systems proficiency
  • Cross-site project management experience
  • Strong communication and problem-solving skills

Key Requirements

  • Minimum 7 years regulated industry experience
  • Bachelor of Science degree required
  • Experience performing cGMP internal/supplier audits
  • Proficiency in biological manufacturing processes

Work Rights

Not specified

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