Senior Program Manager - Cell Therapy Quality & Compliance

Catalent Pharma Solutions; Princeton (NJ); On-site; USD 160,000 - 170,000; Full time

Benefits offered by this job

PTO & holidays

Medical/Dental/Vision on Day 1

Tuition Reimbursement

Green initiatives

Job summary

Catalent, Inc. in Princeton, NJ, seeks a Sr Program Manager to lead quality systems programs including Deviation, CAPA, and Change Control. You will manage investigations, risk assessments, and effectiveness checks, and serve as site SME for quality compliance and continuous improvement.

This role requires strong cross‑functional leadership in a regulated cell therapy environment. Expect collaboration across QA, Manufacturing, and Regulatory teams, ensuring timely milestones, audits, and

Qualifications

• 7+ years of direct experience in project management and/or pharmaceutical industry.
• Bachelor’s degree in science or engineering; advanced degree preferred.
• PM certification (PMP) or related coursework preferred.
• Working knowledge of biologics fermentation, cell culture, purification and analytics.

Responsibilities

• Lead Deviation, CAPA, and Change Control programs to ensure regulatory and quality compliance.
• Manage investigations, risk assessments, root cause analysis, and effectiveness checks.
• Serve as site SME for Quality Systems and drive continuous improvement initiatives.
• Monitor quality metrics and drive cross‑functional governance for timely issue resolution.
• Support regulatory inspections, customer audits, and internal audits.

Skills

Project management

Regulatory compliance

Cross-functional leadership

Quality systems

Biologics knowledge

Education

Bachelor of Science in Science or Engineering

Master of Science / MBA preferred

PMP Certification preferred

Job description

Catalent, Inc. in Princeton, NJ, seeks a Sr Program Manager to lead quality systems programs including Deviation, CAPA, and Change Control. You will manage investigations, risk assessments, and effectiveness checks, and serve as site SME for quality compliance and continuous improvement.

This role requires strong cross‑functional leadership in a regulated cell therapy environment. Expect collaboration across QA, Manufacturing, and Regulatory teams, ensuring timely milestones, audits, and