Sr Supervisor QA Investigations - Raritan, United States - Johnson & Johnson

Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting a Supervisor of Quality Systems Investigations, CAR-T in Raritan, NJ

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity

The Senior Supervisor QA Investigations is responsible for supervising the team involved in quality systems support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Supervise Quality Systems Investigations Team in training, creating metrics, and procedural updates related to non-conformances, investigations, and Corrective and Preventive Actions (CAPAs) in compliance with regulations and guidance.
• Conduct the Instructor-Lead training (ILT) program for the Nonconformance, CAPA, root cause analysis tools, and writing investigations. Provide and govern metrics and data for the certification program.
• Ensure the On-the-job training (OJT) Certification program for Investigators and QA Reviewers is scheduled and working as intended. Coordinate with the Certification program Coaches and QA Investigation department to properly assign and schedule appropriately.
• Responsible for tracking, trending, and presenting data related to investigations and CAPAs for weekly and monthly Quality assessment metrics.
• Drive alignment and efficiency between local and global processes and update the applicable procedures when required.
• Lead and serve as site process owner for the site's Investigations quality system Comet and Track wise.
• Engage in Raritan site level councils/ team meetings, ensuring the CAR-T site needs are represented
• Ensure and maintain a state of inspection readiness; provide front/ back room support during audits
• Retrieve reports and conduct data analysis to support monitoring of 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