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.
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%).
Child care benefits
Short term disability