Senior CQV Lead for GMP Cell Therapy Validation
Katalyst CRO
Katalyst CRO seeks a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing. The role requires owning qualification strategy and execution with a risk-based validation approach aligned to USP, GAMP 5, and industry best practices; you will drive deviations and investigations, author protocols/reports, and support inspection readiness. #J-18808-Ljbffr Katalyst CRO
- Legend Biotech is seeking a Supervisor, QC Microbiology to support cell therapy manufacturing within Quality Operations in Raritan, NJ. You will supervise microbiology lab workflows, ensure cGMP compliance, and support microbiological testing for raw materials, in-process...Suggested
$234.45k - $390.75k
...employees, we are advancing breakthrough therapies in oncology, cardiovascular disease,... ...patient selection strategy.Construct and co-lead Advisory Panels at certain scientific... ...proteomics, immunohistochemistry including assay validation requiredExtensive experience in the...Senior$87.1k - $94.6k
...how it will be done. Key Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety... ...industry - Essential experience in a GMP (Good Manufacturing Practice) environment -...SeniorFor contractorsWorldwide- ...Senior CQV Engineer - Commissioning, Qualification & Validation Contract: 6 months with potential for extension or conversion Location: Raritan,... ...Commissioning, Qualification & Validation) to support a leading cell therapy manufacturing organization in Raritan, NJ....SeniorContract workRelocation
$107.48k - $141.07k
Quality Systems Lead - Legend Biotech Location: Raritan, New Jersey Seniority level: Mid‑Senior level Employment type: Full... ...Jersey, we are developing advanced cell therapies across a diverse array of... ...commercial requirements in a sterile GMP environment. The role serves as...SuggestedFull timeTemporary workWork experience placementWork at officeWorldwideFlexible hoursShift work- TechDigital Group seeks a senior CSV lead with 10+ years in Computer System Validation and strong GxP background. You will guide regulatory-aligned validation efforts, enforce 21 CFR Part 11 compliance, and drive agile processes using JIRA and X-Ray/qTest. The role requires...Senior
$83.71k - $109.87k
Manufacturing Lead Operator, Aseptic Process Raritan, New Jersey, United States Legend... ...we are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...of CAR‑T cell therapy processes, GMP quality systems and their regulatory requirements...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift workAfternoon shift- ...Manufacturing Lead for CAR-T cell therapy production at Johnson & Johnson's Raritan facility. Oversees daily operations of personalized cell therapy manufacturing in a sterile cGMP environment, leading shift teams and ensuring compliance with quality and safety standards...Work at officeShift workDay shift
- ...diverse community of associates with a strong sense of belonging.Learn more about Inclusion & Diversity at PVH here.bout the Role:The Senior Lead, SAP Security, GRC & Compliance will act as a Subject Matter Expert (SME) for SAP Security & GRC including managing multiple SAP...SeniorFull timeContract workWork at officeLocal area
- A global biotechnology company in Raritan, NJ, is seeking a Quality Systems Lead to oversee compliance and quality processes within a cell therapy manufacturing facility. The ideal candidate has a Bachelor's degree in a relevant field, at least 4 years of experience, and...
$146.41k - $192.16k
...advancing the next generation of cell therapy through a portfolio of... ...Legend Biotech is seeking a Senior Engineer / Principal Engineer,... ...robust, scalable processes for GMP manufacturing. The level and scope... ...Tangential Flow Filtration (TFF). Lead or support the translation of...SeniorPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- Johnson & Johnson is seeking a WW Senior Inventory Manager to lead global inventory planning and drive optimal stock levels across regions. The role partners with regional planning, supply network planning, product planning and logistics to ensure commitments are met....Senior
- ...Senior Regulatory Affairs Program Lead position supporting wound closure and healing medical devices at Johnson & Johnson. Leads end-to-end regulatory lifecycle management, new product launches, and global submissions with minimal supervision. Based in Raritan, New Jersey...SeniorRemote work
- Johnson & Johnson's IDAR division seeks a Manager, Regulatory Medical Writing to oversee the preparation and finalization of clinical documents across key therapeutic areas. This hybrid role requires guiding processes, mentoring teams, and participating in cross-functional...SeniorRemote job3 days per week
- ...Senior Manager position leading cryopreservation and cell therapy manufacturing operations at a Raritan, New Jersey facility. The role involves developing long-term... ...relevant manufacturing roles Experience operating in GMP production environments Demonstrated track...Senior
$146.8k - $172.7k
...Senior Manager overseeing analytical science and technology... ...operations for gene therapy programs at a... ...Responsibilities include method validation, analytical data... ...management issues and lead failure investigation reviews... ...requirements Experience with cell-based assays, qPCR,...SeniorContract work$170k - $190k
The Senior Clinical Trial Drug Supply Manager is a critical position... ...Parkinson’s Disease studies); Lead in planning supply strategies... ...randomized arms, combination therapies); Track randomization, study enrollment... ...in alignment with GCP, GMP, GDP, and company SOPs;...SeniorTemporary workWork at officeFlexible hours$87k - $150k
...Description Celltrion is a leading biopharmaceutical company that... ...patients’ access to advanced therapies. We have been at the forefront... ...reports, driving appropriate GMP change control/deviation,... ..., installation, start-up and validation support of process equipment...SeniorContract workTemporary workFor contractorsLocal areaRelocation packageFlexible hoursShift workWeekend work- Role Senior Operations Manager overseeing Cryopreservation, MOI, and... ...for Johnson & Johnson's cell therapy facility in Raritan, NJ. Objectives... ...performing teams. Responsibilities Lead manufacturing operations... ...At least 8 years of relevant GMP manufacturing experience. Prior...Senior
$109k - $174.8k
...new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment... ...Learn more at We are searching for the best talent for a Senior Programming Lead, Oncology. Purpose: The Senior...SeniorFull timeLocal areaImmediate start$238k - $278k
...Inc. (RRD) develops high-impact therapies for devastating rare diseases,... ...medical activitiesOverviewThe Senior Director, North America Field... ...Duties and Responsibilities• Lead and manage a national team of... ...Employee is required to have a valid driver’s license and means of...SeniorWork at officeLocal areaNight shiftWeekend work$97k - $146k
...Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing... ...supervision of the Accounting Manager, the Senior Accountant will be an integral part of... ...transportation. Employee is required to have a valid driver’s license and means of...SeniorWork at officeLocal areaNight shiftWeekend work$137k - $235.75k
...Johnson & Johnson seeks a Senior Manager to lead global diagnostic strategies supporting oncology precision medicine drug development. This... ...diagnostic programs from biomarker hypothesis through clinical validation and companion diagnostic development, with oversight from...Senior$200k - $265k
...Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing... ...- HematologyOverviewThe Senior Director of Marketing is responsible for leading the development and execution of... .... Employee is required to have a valid driver’s license and means of transportation...SeniorWork at officeLocal areaNight shiftWeekend work- ...cloud concepts, cloud applications, etc. In addition to validation and regulation experience, the resource should have the... ...Validations 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical,...SeniorRemote work
$138k - $172k
...Senior Facilities Manager Job TitleSenior Facilities Manager... ...development, clinical and advanced cell therapies for the industry's top... ...role will be responsible for leading site facilities strategy, building... ...compliance requirements; GMP/GLP environment experience strongly...SeniorTemporary workFor contractorsWork at officeLocal areaWorldwideShift work$240k - $300k
...Executive Committee, and senior business leaders, the... ..., cybersecurity, validation, audit, and data integrity... ...experience.Experience leading teams, managing change... ...innovative therapies for rare and ultra-rare... ...provided mobile phone or cell phone stipend Additional...SeniorContract workTemporary workWork experience placementWork at officeFlexible hours2 days per week3 days per week- TechDigital Group in New Jersey is seeking a Quality Manager, Clinical Supply Chain Quality to ensure GMP/GDP compliance for Clinical Supply Chain Logistics and coordinate with global teams and vendors. The role emphasizes quality oversight across warehouses, inspections...
$23.04 - $30.72 per hour
...Bridgewater, NJ/Laboratory Chemical Division (LCD) This is a Lead Transportation Coordinator position in the LCD Transportation department... ...providers, and manufacturers rely on to develop breakthrough therapies, improve patient outcomes, and make the world healthier,...Hourly payFull timeTemporary workWork at officeDay shift$294.48k - $386.51k
...we are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...Director, Multiple Myeloma Pipeline Lead as part of the Clinical Development... ...-offs, risks, and investment options to senior leadership and portfolio-review committees...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CQV Lead for GMP Cell Therapy Validation. Be the first to apply!
- senior implementation project manager Raritan, NJ
- senior database analyst Raritan, NJ
- senior international accountant Raritan, NJ
- senior scientific director Raritan, NJ
- senior lead project manager Raritan, NJ
- senior Raritan, NJ
- remote senior project manager Raritan, NJ
- senior performance engineer Raritan, NJ
- senior software engineer remote Raritan, NJ
- senior medical director medical affairs Raritan, NJ




