Compliance Manager

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

Job Function:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium

Job Description:

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/

J&J Innovative Medicine is recruiting for a Compliance Manager reporting to the Large Molecule Regulatory Compliance Lead and to be based in Gent or Beerse (Belgium).

Position Summary

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.

Major Responsibilities:


* 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 Af...