Johnson & Johnson Careers
Compliance & Systems Manager, CAR-T Manufacturing
Requisition ID: 8125180807
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Compliance & Systems Manager, CAR-T Manufacturing. The position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Compliance & Systems Manager, CAR-T Manufacturing is responsible for quality systems and compliance oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Responsibilities include but are not limited to:
- Work with Process Development team and Operations organization to successfully transfer process to cGMP facility to manufacture products.
- Set up the appropriate quality systems and provide robust guidance to design and support the facility through creation of all new documents to support production, ensuring compliance with applicable regulations and Janssen standards.
- Support/lead regulatory health authority inspections and lead inspection readiness.
- Oversight and maintenance of applicable Quality Agreements.
- Represent the site for establishment and implementation of Company-wide quality policies, strategies and practices.
- Set up and maintain key performance indicators.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
- A minimum of 8 years of experience in Quality Assurance/ Quality Systems related to manufacturing is required.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research & Development is preferred.
- Experience working with Quality systems is required.
- Experience with quality support in clinical manufacture or NPI is preferred.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- Manufacturing of cell based products as well as knowledge of Good Tissue Practices is preferred.
- Experience working with senior leaders and/or stakeholders is required.
- Comfortable with speaking and interacting with inspectors
- Good written and verbal communication skills are required.
- This position will require occasional travel to Malvern, PA or Spring House, PA as business demands.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson Family of Companies are equal
opportunity employers, and all qualified applicants
will receive consideration for employment without
regard to race, color, religion, sex,
sexual orientation, gender identity, genetic
information, national origin, protected veteran
status, disability status, or any other
characteristic protected by law.
United States-New Jersey-Raritan
Janssen Pharmaceuticals, Inc (6062)