Site Based Compliance Manager
Description:
Janssen Supply Group is recruiting for a Site Based Compliance Manager, located in Raritan, NJ!
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/.
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
Qualifications:
Education:
- A Bachelor’s Degree in Science, Engineering or related field is preferred
Required:
- A minimum of 6 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 15% travel
- The salary for this role is anticipated to be between $95,000 and $150,000
- Employees and/or eligible dependents may be 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.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
