Sr. 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:
Leiden, South Holland, Netherlands, Sassenheim, Netherlands

Job Description:

Essential Job Duties and Responsibilities 

Execute internal audit program at the Pharmaceutical manufacturing sites.

Prepare and manage external GMP audits and inspections (e.g.

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

Deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance. 

 

Site internal audit program: 


* 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 to COMET 

Facilitate and/or 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 

Support identification of changes in regulations and gap assessments related to compliance procedures: 


* Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices.  



* Implement J&J Compliance Stds (e.g.

Audit/Inspection Mgt) and partner with sites on J&J standard implementation (Sr.) 

Participate on project teams, as requested: 



* 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 

Regulatory compliance documentation and remediation plans 


* Receive regulatory comp...