Senior Program Manager – Cell Therapy Quality & Compliance

Catalent

Princeton (NJ)

On-site

USD 160,000 - 170,000

Full time

21 hours ago
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Benefits offered by this job

Career growth
Paid time off
8 holidays
Benefits from day one

Job summary

Catalent's Princeton, New Jersey site is a key part of the company's cell therapy network, supporting CGMP manufacturing for autologous and allogeneic therapies. The Sr Program Manager will lead cross-functional teams, manage investigations and CAPAs, and ensure milestones are met with a solutions-oriented mindset in a dynamic environment.

The role requires strong project management, regulatory alignment, and site-level quality system expertise to drive continuous improvement and successful

Qualifications

  • Bachelor of Science in Science or Engineering or equivalent required; advanced degree preferred.
  • 7+ years of project management experience in pharma or related field.

Responsibilities

  • Lead and oversee Deviation, CAPA, and Change Control programs to ensure compliance.
  • Manage investigations, CAPAs, and change controls lifecycle including RCA and effectiveness checks.
  • Serve as site SME for Quality Systems, providing guidance and training.
  • Monitor quality metrics, drive process improvements, and lead governance forums.
  • Support regulatory inspections, audits, and continuous improvement initiatives.

Skills

Project management
CAPA
Deviations
Change control
Regulatory compliance
Quality systems
Cross-functional leadership

Education

Bachelor of Science in Science or Engineering
Advanced degree (MS/MBA/PhD) preferred

Job description

Catalent's Princeton, New Jersey site is a key part of the company's cell therapy network, supporting CGMP manufacturing for autologous and allogeneic therapies. The Sr Program Manager will lead cross-functional teams, manage investigations and CAPAs, and ensure milestones are met with a solutions-oriented mindset in a dynamic environment.

The role requires strong project management, regulatory alignment, and site-level quality system expertise to drive continuous improvement and successful

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