Senior compliance specialist CAR-T

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%).