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Become part of a new organization! Own the internal audit program at the Belgium CAR-T Pharmaceutical manufacturing sites. Prepare for and support external GMP/ATMP audits and inspections. Provide compliance subject matter expertise to the manufacturing sites and site-based projects.
- Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
- Organize and complete compliance walk-throughs (e.g. GEMBA)
- Evaluate responses to internal audits
- Enter internal audit data into quality system
Support external GMP audits and inspections (Health Authority, Customer). Including:
- Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching).
- Partner with Quality to manage inspections (host and/or coordinate front room and back room, issue daily inspection summaries).
- Prepare/review site responses and associated CAPA for Health Authority/Customer inspections.
- Identify changes in regulations that impact compliance procedure, perform comparisons against current practices.
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
Partner with site for execution of proactive compliance scans.
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.
- 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.
- Bachelor’s degree in science or related field
- At least 7 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience.
- Knowledge of global GMP and ATMP regulations is required.
- Preferred experience and knowledge of/with Advanced Therapies and/or CAR-T.
- Strong analytical skills. Ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance communities.
- Delivers on commitment timelines and has high sense of urgency.
- Experience performing internal or external audits of GMP regulated facilities.
- Domestic travel is possible
- Approximately 10-15% travel.
- QA/RA certification is preferred.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.