On-Floor QA Operations Manager – Cell Therapy

Catalent Pharma Solutions; Princeton (NJ); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401K benefits

152 hours PTO + 8 holidays

Job summary

Catalent is seeking a Manager, Quality Assurance Operations for our on-site cell therapy manufacturing facility in Princeton, NJ. You will provide on-the-floor QA oversight, review batch records, manage deviations, and support release decisions for clinical and commercial products.

The role requires a bachelor's in science/engineering with 7+ years in GMP pharma, 3+ years in leadership, strong regulatory knowledge, and excellent communication.

Qualifications

• Bachelor’s degree in Science, Engineering, or related discipline required; advanced degree preferred.
• Minimum 7+ years in GMP-regulated pharma/biologics manufacturing.
• Minimum 3 years of leadership or supervisory experience.
• 5+ years QA experience supporting manufacturing operations; on-the-floor QA required.
• Experience with batch records, deviations, CAPAs, change control in manufacturing.
• GMP regs knowledge incl. 21 CFR Parts 210/211, 600-series, EU GMPs, ICH; cell therapy/aseptic preferred.
• Excellent English written and verbal communication; cross-functional collaboration.

Responsibilities

• Provide real-time QA on-the-floor support for cell therapy manufacturing.
• Perform GMP walkthroughs and ensure GDP compliance.
• Review batch records, logbooks, and release decisions for products.
• Support supplier qualification activities and material investigations.
• Participate in regulatory inspections and client audits.
• Lead QA team guidance and training within QA Operations.

Skills

QA on-the-floor leadership

Regulatory GMP knowledge

Batch record review

Deviation investigations

Change control experience

Leadership / coaching

Cross-functional collaboration

English communication

Education

Bachelor’s degree in Science, Engineering, or related discipline

Advanced degree preferred

Job description

Catalent is seeking a Manager, Quality Assurance Operations for our on-site cell therapy manufacturing facility in Princeton, NJ. You will provide on-the-floor QA oversight, review batch records, manage deviations, and support release decisions for clinical and commercial products.

The role requires a bachelor's in science/engineering with 7+ years in GMP pharma, 3+ years in leadership, strong regulatory knowledge, and excellent communication.