Director, Quality Systems Compliance
Location:
Raritan , New Jersey
Posted:
March 31, 2017
Reference:
2879170221/2-en-us

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  We are currently recruiting for a Director, Quality Systems Compliance, to be based at a J&J facility in NJ or PA.  
 
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world.  With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
 
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management.
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
 
 
  • Owns the processes for deployment of internal/external standards to Janssen.  This includes oversight of monitoring, assessment and implementation activities.
  • Leads global deployment activities for select external standards/regulations impacting global Quality Systems.
  • Provides strategic direction to ensure internal audit programs are adequately scoped and executed to account for new/emerging regulations and standards. 
  • Drives simplification and standardization of audit process and execution across Janssen to ensure compliance with new and emerging regulatory standards and requirements.    
 
  • Acts as Global Owner of the Janssen Adopting Regulatory Requirements (ARR) process.  Leads cross-functional Council meetings and drives process improvements to ensure monitoring, identification, assessment, and implementation of new or revised regulatory requirements and standards impacting Quality Systems.  Develops and reports metrics to ensure management awareness of risks and adherence to the process. 
  • Leads implementation initiatives for new or revised external standards and regulations impacting Global Quality Systems.  Develops and manages cross-functional matrix teams to ensure gap and impact assessments are executed and remediation plans are in place.  Develops and reports metrics to ensure management awareness of status.
  • Manages the process for deployment of internal J&J Standards into the Pharmaceutical Segment.  Identifies Process Owners and Functional Area representatives, trains owners on requirements for Sector-level assessment, and monitors the status of gap assessment and deployment across end-to-end functions of Janssen.
  • Participates in Enterprise Regulatory Outreach forum as a key link between Pharma, J&J Regulatory Compliance, and other Segments across J&J.
  • Participates as Pharma representative on Enterprise alignment projects related to external standards monitoring and audit standardization.  Works to simplify and standardize processes across Janssen. 
  • Leads integration activities to assure inclusion of new/emerging regulatory requirements (e.g combination products) into applicable Janssen Global Quality Systems and internal audit processes.  
  • Ensures internal audit procedures remain current and up-to-date, and all applicable global and virtual organizations are subject to appropriate audit cadence.  In partnership with J&J Regulatory Compliance, ensures audit planning and execution to ensure compliance with J&J policies. 
  • Plans and manages budget.
  • As needed, provides compliance support in relation to new or emerging regulations (e.g. awareness training, supporting the development of remediation plans, attending and presenting at external conferences to shape external environment, etc.).
 

Qualifications
  • A minimum of a Bachelor’s Degree with at least ten (10) years of related experience in the pharmaceutical or similarly regulated industry is required. 
  • Experience in both medical device and pharmaceutical industries is preferred.   
  • Minimum of five (5) years of experience working with Quality Systems is required (change control, CAPA, audit, etc.).  
  • Current Auditor Certification (CQA, ISO Lead Auditor, etc.) is strongly preferred. 
This position can be based at any J&J facility in NJ or PA and may require up to 15% travel, domestic/international.
 
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-New Jersey, North America-United States-Pennsylvania
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Systems
Requisition ID
2879170221

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.