{"id":4318235,"url":"https://alion.io/job/catalent-manager-quality-assurance-operations","title":"Manager Quality Assurance Operations","company":{"id":1785256,"name":"Catalent","domain":"catalent.com","url":"https://alion.io/company/catalent-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Princeton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-15T04:04:23Z","board_verified":true,"closed_at":null,"days_open":20,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":20},"description":"Job Description\nManager, Quality Assurance Operations\nPosition Summary:\nWork Schedule: Monday - Friday, 8:00am-5:00pm.\n\n100% on-site\n\nCatalent 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.\nWith advanced technologies, deep expertise and a worldwide network, we partner with innovators to transform bold ideas into life-changing therapies and self-care solutions.\nOur 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.\nThe 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.\nThe Manager, QA Operations, reports to the Director, Quality and may have direct reports including QA Specialists or Senior Specialists supporting manufacturing operations.\nThe Role:\nProvide real-time QA on-the-floor support for cell therapy manufacturing operations, including aseptic processing, cell handling, cryopreservation, fill/finish, and material handling activities.\n\nPerform GMP walkthroughs and observe critical manufacturing steps to ensure compliance with approved procedures, batch records, and Good Documentation Practices (GDP).\n\nSupport manufacturing personnel during execution of complex or high-risk operations to ensure quality, compliance, and right-first-time execution.\n\nReview executed batch production records, logbooks, and associated GMP documentation for accuracy, completeness, and regulatory compliance.\n\nSupport timely batch record review and participate in lot disposition and release decisions for clinical and commercial products.\n\nPerform QA review, approval, and release of raw materials, consumables, and critical reagents used in cell therapy processing.\n\nReview, assess, and approve deviations, nonconformances, investigations, CAPAs, and change controls impacting manufacturing operations, facilities, equipment, or materials.\n\nSupport supplier qualification activities, material-related investigations, and ensure material qualification documentation meets internal and regulatory requirements.\n\nSupport inspection readiness activities and participate in regulatory inspections and client audits to ensure adherence to the Catalent Quality Management System (QMS), site SOPs, and global standards.\n\nProvide day-to-day leadership and QA guidance while collaborating cross-functionally with Manufacturing, Supply Chain, MS&T, Validation, and Regulatory Affairs, and supporting QA Operations training and development.\n\nOther duties as assigned.\n\nThe Candidate: \nBachelor’s degree in Science, Engineering, or related discipline required; advanced degree preferred.\n\nMinimum of 7 years of experience in a GMP-regulated pharmaceutical, biologics, or cell/gene therapy manufacturing environment.\n\nMinimum of 3 years of Prior leadership or supervisory experience required, with demonstrated ability to coach and manage performance.\n\n5+ years of Quality Assurance experience supporting manufacturing operations; direct QA on-the-floor experience required.\n\nDemonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.\n\nDemonstrated experience supporting GMP operations, including batch record review, lot disposition, deviation investigations, change control, and work performed in manufacturing and cleanroom environments.\n\nStrong knowledge of GMP regulations and guidance, including 21 CFR Parts 210/211, 600-series (biologics), applicable EU GMPs, and ICH guidelines; cell therapy, ATMP, or aseptic processing experience strongly preferred.\n\nExperience with raw material qualification and release activities; supplier quality experience preferred.\n\nStrong written and verbal communication skills in English, with the ability to work cross-functionally under tight timelines, manage multiple priorities with high attention to detail, and willingness to successfully complete required visual acuity testing (including Graham Field Eye Test Chart and Ishihara Color Vision Test).\n\nThe anticipated salary range for this position in New Jersey is $130,000 - $160,000 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.\nWhy you should Join Catalent:\nDefined career path and annual performance review and feedback process.\n\nDiverse, inclusive culture.\n\nPotential for career growth on an expanding team.\n\nCross-functional exposure to other areas within the organization.\n\n152 hours of paid time off annually + 8 paid holidays.\n\nMedical, dental, vision and 401K benefits effective day one of employment.\n\nTuition Reimbursement.\n\nCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.\npersonal initiative. dynamic pace. meaningful work.\nVisit Catalent Careers to explore career opportunities.\nCatalent is an Equal Opportunity Employer, including disability and veterans.\nIf you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.\nNotice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.\nImportant Security Notice to U.S. Job Seekers:\nCatalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to  for us to investigate with local authorities.\nCalifornia Job Seekers can find our California Job Applicant Notice HERE.\nVolunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.\nMassachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.","description_format":"text","description_chars":8647,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["401k plan"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Dietary Supplements","Contract Manufacturing","CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-14T17:28:40Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.857,"p_room":0.9,"age_days":20,"expected_fill_days":33,"reasons":["conf:0","win:mid","comp:brand"],"computed_at":"2026-11-15T04:25:45Z"},"pay":null,"html_url":"https://alion.io/job/catalent-manager-quality-assurance-operations","json_url":"https://alion.io/job/catalent-manager-quality-assurance-operations.json","meta":{"generated_at":"2026-11-15T04:25:45Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":449,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1785256},"rest":"https://alion.io/mcp/rest/get_company?id=1785256"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcatalent-manager-quality-assurance-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcatalent-manager-quality-assurance-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcatalent-manager-quality-assurance-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/catalent-manager-quality-assurance-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcatalent-manager-quality-assurance-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4318235}},{"tool":"search_jobs","arguments":{"company":"catalent.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4318235},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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