Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Apheresis Clinical Site Quality Manager. The position will be remote within the United States.
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 candidate will be part of the quality team responsible for the audit and qualification of all hospital sites related to the collection of Apheresis Material used in autologous CAR-T products for clinical trials and commercial treatment. Job duties are performed within a team according to an assigned audit schedule.
Responsibilities include but are not limited to:
• Audit clinical sites to ensure compliance with Janssen requirements.
• Performs duties under limited supervision and according to standard operating procedures.
• Maintains GMP Trackwise audit records
• Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices, Chain of Custody, Chain of Identity
• Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
• Strive to reduce non-conformances in supported areas by dedicating to driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Other duties will be assigned, as necessary.
- Minimum of a Bachelor’s degree in Engineering, Science, Medical or equivalent technical discipline is required
- Minimum of 4-6 years of experience in Quality Assurance related to manufacturing is required, preferably in clinical quality, cell therapy, or Research & Development.
- A minimum of 4 years of experience with quality support in clinical manufacturing or Clinical Auditing is required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products is required
- Knowledge of Good Tissue Practices required
- Ability to pay attention to details and following procedures is required
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- The successful candidate must maintain written records in the form of audit reports.
- Flexible to travel is a must with approximately 50% travel required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
JANSSEN SUPPLY GROUP, LLC (6046)