Janssen Supply Group, LLC is recruiting for a Director, Quality
Operations (External Manufacturing) to be based out of Horsham, PA or Raritan,
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
- 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
- Provide support to manufacturing / logistics
organizations regarding aspects of GMP compliance associated with technology
transfer and international manufacturing.
- 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
- Experience working with cell therapies is
- Demonstrated experience with all dosage forms,
specifically in biologics and new products, is preferred.
- Experience with regulatory reporting of BPDR or FAR
- This position will be based in either Horsham,
PA or Raritan, NJ and depending on business needs may require up to 30% travel.
United States-Pennsylvania-HorshamOther Locations
North America-United States-New Jersey-RaritanOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function