Compliance Specialist

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

Job Description:

The Innovative Medicines Regulatory Compliance (IMRC) organization is recruiting for a Compliance Specialist! This position will be based in Beerse.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science.

We are Janssen.

We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com and follow us @JanssenGlobal.

Janssen Pharmaceutica NV is part of the Janssen Pharmaceutical Companies.

Are you interested in making a difference in a growing diverse company? Apply today for this phenomenal opportunity!

This position will execute internal audit program at the pharmaceutical manufacturing sites, prepare for and support external GMP audits and inspections (e.g.

Health Authority, Customer, ERC, etc.) and provide compliance subject matter expertise to the manufacturing sites and site based projects.

Key Responsibilities:



* Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)


* Execute compliance walk-throughs (e.g.

GEMBA)


* Evaluate responses to internal audits


* Enter internal audit data in Internal Audit 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, daily inspection summaries)


* Review site response and associated CAPA for Health Authority inspections


* Provide input to daily inspection summaries, as needed"


* Identify changes in regulations that impact compliance procedure, perform gap analysis 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 mtgs, etc.


* Partner with site for execution of proactive compl...