Director, Quality Operations (External Manufacturing)
Location:
Raritan , New Jersey
Posted:
January 23, 2017
Reference:
5619161222/2-en-us

Janssen Supply Group, LLC is recruiting for a Director, Quality Operations (External Manufacturing) to be based out of Horsham, PA or Raritan, NJ.

 

Janssen Supply Group, LLC is part of Janssen Supply Chain (JSC), a global organization responsible for supplying medicines to markets around the world.  With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.

 
The Director, Quality Operations (External Manufacturing) will:
 
  • Provide Quality Assurance, Compliance and Technical Support for External Manufacturers in North America.
  • Provide leadership in the selection, development and management of External Manufacturers in the Americas region.
  • Provide Quality Assurance support for technology transfer and improvement of existing manufacturing processes.
  • Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products.
  • Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
  • Direct all of the Quality and Compliance activities of External Manufacturing in the North America Region and provide the proper interface to External Supply Integration and JSC Internal Manufacturing.
  • Act as senior level interface to key Health Authorities in the region for all of JSC External Manufacturing.
  • Prepare and manage internal and external regulatory audits for JSC External Manufacturing.
  • Interface with the Product Management and Customer Management teams to supply the markets.
  • Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
  • Provide cGMP compliance support to External Manufacturers by investigating and resolving quality issues.
  • Coordinate and provide concurrences on deviations, change controls and CAPAs.
  • Travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight.
  • Develop, implement, and review of SOPs for interactions with External Manufacturers.
  • Apply cGMP regulations and other Health Authority and international requirements to all aspects of the position.
  • Coordinate change control documentation and approval process.
  • Provide support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and international manufacturing. 


Qualifications
  • A minimum Bachelor's degree (or equivalent degree) in Science or Engineering is required. 
  • A minimum of 10 years’ experience in Pharmaceutical/Medical Device/Biotech/OTC/Consumer industry is required.
  • Strong knowledge of and/or experience with all of the following is required: External Manufacturing, Technology Transfers, CMC Process and Quality Event Management. 
  • Quality Audit Management (Inspection readiness, internal/external regulatory audits) experience is required. 
  • Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required.
  • Experience working with large molecules is highly preferred.
  • Experience working with cell therapies is desired.
  • Demonstrated experience with all dosage forms, specifically in biologics and new products, is preferred.  
  • Experience with regulatory reporting of BPDR or FAR is preferred.
  • This position will be based in either Horsham, PA or Raritan, NJ and depending on business needs may require up to 30% travel. 


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

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