Catalent
pharmaceutical, biotech, self-care, cell therapy
Manager,QualityAssuranceOperations
Neural analysis suggests this role is
optimal for Senior candidates.
“Manager, Quality Assurance Operations at Catalent. Skills: Quality Assurance, GMP, Manufacturing Operations, Leadership. Provide real‑time QA on‑the‑floor support for cell therapy manufacturing operations. Perform GMP walkthroughs and observe critical manufacturing steps”
Industry & Context.
deviation management; nonconformances; investigations; CAPAs
100% on-site, required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test)
What They're Looking For.
Must Have
Minimum of 7 years of experience in a GMP-regulated pharmaceutical, biologics, or cell/gene therapy manufacturing environment, Minimum of 3 years of Prior leadership or supervisory experience required, 5+ years of Quality Assurance experience supporting manufacturing direct QA on-the-floor experience required, Demonstrated experience supporting GMP operations, including batch record review, lot disposition, deviation investigations, change control, and work performed in manufacturing and cleanroom environments, written and verbal communication skills in English
Nice to Have
advanced degree preferred, knowledge of GMP regulations and guidance, including 21 CFR Parts 210/211, 600‑series (biologics), applicable EU GMPs, and ICH cell therapy, ATMP, or aseptic processing experience strongly preferred, Experience with raw material qualification and release supplier quality experience preferred
What You'll Do.
Provide real‑time QA on‑the‑floor support for cell therapy manufacturing operations
Perform GMP walkthroughs and observe critical manufacturing steps
Support manufacturing personnel during execution of complex operations
Review executed batch production records
and associated GMP documentation
Support timely batch record review and participate in lot disposition and release decisions
and release of raw materials
and critical reagents
and approve deviations
Support supplier qualification activities and material‑related investigations
Support inspection readiness activities and participate in regulatory inspections and client audits
Provide day‑to‑day leadership and QA guidance
How You'll Work.
Team & Collaboration
collaborating cross‑functionally with Manufacturing, Supply Chain, MS&T, Validation, and Regulatory Affairs
Communication Scope
written and verbal communication skills in English; ability to work cross‑functionally under tight timelines; manage multiple priorities with high attention to detail
Full Job Description
**Manager, Quality Assurance Operations** ** _Position Summary:_** * **Work Schedule: Monday – Friday, 8:00am-5:00pm.** * **100% on-site** 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. With advanced technologies, deep expertise and a worldwide network, we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions. Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The Manager, Quality Assurance Operations – Cell Therapy provides on-the-floor Quality Assurance (QA) oversight for GMP cell therapy manufacturing operations. This role ensures compliant execution, review, and disposition of manufacturing activities, materials, and documentation associated with clinical and commercial cell therapy products. Responsibilities include QA presence in processing areas, batch record review, lot disposition, raw material release, deviation management, and direct support of aseptic and cell processing operations. The Manager, QA Operations, reports to the Director, Quality and may have direct reports including QA Specialists or Senior Specialists supporting manufacturing operations. **_The Role:_** * Provide real‑time QA on‑the‑floor support for cell therapy manufacturing operations, including aseptic processing, cell handling, cryopreservation, fill/finish, and material handling activities. * Perform GMP walkthroughs and observe critical manufacturing steps to ensure compliance with approved procedures, batch records, and Good Documentation Practices (GDP). * Support manufacturing personnel during execution of complex or high‑risk operations to ensure quality, compliance, and right‑first‑time execution. * Review executed batch production records, lo
Applying for this Manager, Quality Assurance Operations role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Catalent?
Real rants from real employees. Read before you apply.