Manager GxP Systems Oversight at Johnson & Johnson

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at Job Function: Supply Chain EngineeringJob Sub Function: Quality EngineeringJob Category:People LeaderAll Job Posting Locations:Raritan New Jersey United States of AmericaJob 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 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 & Johnsons Credo and Leadership Imperatives into team goals and decision-making processes.Qualifications:Education:Minimum of a Bachelors 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 or contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:The anticipated base pay range for this position is :$100000 to $172500Additional 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 Companys 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. 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 marketRequired Experience:Manager Key Skills ABAP,Information Technology Sales,Investment Management,Landscape,Maintenance,Clinical Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 100000 - 172500