Site Based Compliance Manager

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:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently seeking a Site Based Compliance Manager to join our Regulatory Compliance team located in Raritan, NJ.
The Site Based Compliance Manager is highly visible to the Raritan site Leadership team and ensures understanding and alignment of the site to global regulatory compliance initiatives and executes local programs to ensure compliance at the site.
 

Key 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).
• 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
• 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.
   

The Site Based Compliance Manager, reports to the Associate Director, Regulatory Compliance for Large Molecule and Advanced Therapies, and is primarily responsible for leading key aspects of site based compliance activities and supports attainment of strategic goals and objectives.

Key responsibilities:

• 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;
• Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.;
• Implement proactive compliance activities;
• Manage tracking and reporting of all site compliance key performance indicators;
• Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards;
• Co-authors, review and revise compliance procedures;
• Review significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions;
• Participate in and Coordinate Mock Recalls;
• Review and participate in Quality Risk Assessments
   

The Site Based Compliance Manager is highly visible to the Raritan site Leadership team and ensures understanding and alignment of the site to global regulatory compliance initiatives, and executes local programs to ensure compliance at the site.
 

Qualifications:

• A minimum of a Bachelor’s degree in Science, Engineering, or a related field is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 6 years of relevant business experience in a GMP-regulated industry, inclusive of regulatory compliance experience is required.
• 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 is preferred.
• Experience or Certification performing internal or external audits of GMP regulated facilities is preferred (ASQ or equivalent).
• Strong analytical skills are required to prepare and understand metrics and reports.
• Applicants must clearly articulate issues and findings from auditing actions.
• Must have excellent communication skills, and be able to quickly build credibility within the internal Quality and Compliance communities, and with operations teams.
• Up to 15% domestic and international travel may be required as business demands.

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-$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 Co-Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension) Positions Represented by CBA: This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement. 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.