Beschreibung
Janssen Pharmaceutica, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Compliance Specialist CAR-T. The position will be based in Ghent Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.
The Senior Compliance Specialist CAR-T is responsible to execute the internal audit program at the CAR-T manufacturing/testing sites and to prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc). The Senior Compliance Specialist CAR-T shall provide compliance subject matter expertise to the manufacturing/testing sites and site-based projects and will deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance.
Major Responsibilities
- Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report),report), including:
o Execute compliance walk-throughs (e.g. GEMBA)
o Evaluate responses to internal audits
o Enter internal audit data in to TrackWise
- Facilitate and/or support external GMP audits and inspections (Health Authority, Customer), including:
o Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
o Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)
o Review site response and associated CAPA for Health Authority inspections
o Provide input to daily inspection summaries, as needed
- Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Standards (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation.
- Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
- Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.
- Partner with site for execution of proactive compliance scans.
- Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc) to proactively identify risks and drive compliance improvement across the site.
- As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc).
- Collaborate with other groups in PRC and JJRC to support execution of independent audits and special assessments. Support site during ERC audits (e.g. document review, front/back room support). Review and provide input to site response, and associated CAPA, to ERC audits.
- Ensure timely and accurate reporting of compliance metrics.
- Coordinate compliance training for the site.
- Connect with external groups (e.g. PDA, ISPE, etc) to benchmark industry standards.
- As needed, co-author, 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.
- Domestic travel is possible (10-15%).
Befähigungen
Required:
- Bachelor's Degree in Science or related field.
- At least 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.
- Strong knowledge of global GMP regulations is required.
- Strong analytical skills. Ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community.
- Delivers on commitment timelines and has high sense of urgency.
- Experience preparing for inspections, managing inspections and/or supporting inspections.
Preferred:
- QA/RA certification is preferred.
- Experience performing internal or external audits is strongly preferred.
- Experience in change management and project management.