Manager GxP Systems Oversight

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. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Manager GxP Systems Oversight to join our team.

This is an onsite position located in Raritan, NJ.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality and reliable supply of our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

Summary:

The GxP Systems Manager will lead a team dedicated to ensuring compliance across Engineering, Maintenance, Facilities and Automation functions.

The ideal candidate will demonstrate leadership and exceptional presentation skills to effectively manage and influence cross-functional teams, foster a culture of compliance, and clearly communicate complex regulatory requirements.

This role involves overseeing SOP revisions, CAPAs, Change Controls, audits, and investigations, with a proactive focus on continuous improvement and operational excellence.

Key Responsibilities:


* Lead investigations related to Engineering, Maintenance, and Utilities systems, automation, including data collection, root cause analysis, and coordinating cross-functional meetings.


* Drive continuous improvement initiatives to enhance team performance and GxP metrics.


* Track and ensure the timely completion of CAPAs resulting from investigations, audits, and compliance assessments.


* Oversee the revision process of SOPs alignment with global standards for Engineering, Maintenance, automation and Utilities to ensure regulatory compliance and operational accuracy.


* Conduct gap analyses to identify areas for improvement in systems related to QMS compliance.


* Develop and deliver training programs on GxP SOPs and compliance requirements, providing technical support to the teams.


* Serve as the primary conta...