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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 contact during regulatory and internal audits and inspections, ensuring site readiness and compliance.

+ Propose and implement innovative solutions to strengthen compliance posture, operational efficiency, and continuous improvement.

+ Integrate Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision-making processes.

Qualifications:

Education:

+ Minimum of a Bachelor’s degree required, focus in Engineering, Life Sciences, or a related field preferred.

Experience and Skills:

Required:

+ Minimum 7 years of relevant experience required, experience in biologics, cell therapy, or related biopharmaceutical operations in Engineering, validation and maintenance is preferred.

+ Demonstrated experience of cGxP regulations, FDA, EMA and other regulatory agencies.

+ Proven track record managing compliance activities, audits, CAPAs, and SOP revisions.

+ Experience performing risk assessments, gap analyses, and implementing corrective actions.

+ Familiarity with QMS (Quality Management Systems) and validation processes.

+ Excellent communication and interpersonal skills, capable of training and influencing diverse teams.

+ Analytical mindset with strong problem-solving skills.

+ Proactive approach to continuous improvement and process optimization.

+ Demonstrated ability to manage multiple projects and priorities efficiently.

+ Proficiency with project management tools (MS Project, Excel, Vision, SharePoint).

+ Foster a collaborative environment that promotes teamwork, continuous improvement, and adherence to regulatory standards.

+ People leadership/management experience (direct or indirect reports)

Preferred:

+ Skilled in data analysis and reporting tools.

Other:

+ May require up to 20% domestic and/or international travel.

+ The role involves working in a regulated biopharmaceutical environment, which includes standing, sitting, climbing stairs, and light lifting.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$100,000 to $172,500

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market