We are desiring to recruit a resourceful Site Based Compliance Manager to join our collaborative team at Johnson and Johnson in Raritan, NJ.
Growing your career as a Full Time Site Based Compliance Manager is a terrific opportunity to develop competitive skills.
If you are strong in project management, planning and have the right commitment for the job, then apply for the position of Site Based Compliance Manager at Johnson and Johnson today!
Janssen Supply Group is recruiting for a Site Based Compliance Manager, located in Raritan, NJ!
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.
Become part of an exciting organization at the forefront of advanced therapies! Own the local internal audit program of the Pharmaceutical manufacturing and Quality Control operations. Prepare for and support external GMP audits and Health Authority inspections. Provide compliance subject matter expertise to the manufacturing sites and site based projects.
Key Responsibilities: Major Responsibilities: Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report, and evaluate responses) at the site, and participate in internal audits at other sites Organize and complete compliance walk-throughs (e.g. GEMBA) of the supported areas and issue reports based on findings Own internal audit data in the quality system including metrics, and reporting of this data Support inspections (Health Authority, Customer). Including: Inspection Readiness i.e. audit preparation, scheduling, manage mock inspections, coaching, response writing and review, and direct contact with Health Authority representatives. Partner with Quality to manage inspections of the facility (schedule, host and/or coordinate front room and back room, and issue daily inspection summaries) Prepare/review site responses and associated CAPA for Health Authority/Customer inspections, and manage communications with the representatives Proactively identify and review changes in regulations that impact compliance procedure, perform comparisons, and lead gap assessments against current practices. Be a Subject Matter Expert (SME) for site personnel, Quality Systems and/or projects. Review complaints and field action investigations. May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc. Implement proactive compliance activities. Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc) to proactively identify risks and drive compliance improvement across the site. Other Duties: Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards As needed, co-authors, review and revise compliance procedures. As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions Conduct Mock Recalls Review and participate in Quality Risk Assessments for the site Required: A minimum of 8 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience. Strong analytical skills to prepare and understand metrics and reports. Applicants must clearly articulate issues and findings from auditing actions. Must have excellent interpersonal skills, and be able to quickly build credibility within the Quality and Compliance communities, and with operations teams. Delivers on dedication timelines and assigned tasks. Experience performing internal or external audits of GMP regulated facilities. Preferred: Knowledge of cGMP regulations and FDA/EU Guidance related to the manufacture of biologics or advanced therapy medicinal products is required. Knowledge of Good Tissue Practices QA/RA certification is preferred. Other: Domestic and international travel is possible up to approximately 10-15% travel The salary for this role is anticipated to be between $95,000 and $150,000 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.
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Benefits of working as a Site Based Compliance Manager in Raritan, NJ:? Career Growth Potential
? Company offers career progression opportunities
? Generous Compensation
