Manager, Supplier Quality
Location:
Vacaville , California
Posted:
January 27, 2017
Reference:
000018IH/3-en-us

Janssen Supply Group, LLC is recruiting for a Manager, Supplier Quality to be based at or work remotely near the following Janssen sites:  Athens, GA; Manati, Puerto Rico; or Vacaville, CA. Candidate must be willing to be located within commutable distance to one of these locations.

 

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

 
The Manager, Supplier Quality will:
  • Provide quality management for a portfolio of suppliers; monitor the quality parameters for the assigned suppliers and to report on their performance on a regular basis. This includes the supply chain of Active Pharmaceutical Ingredients (API), Large Molecule formulated bulk and product, raw materials, chemicals, components, excipients, packaging materials, medical devices, and other materials & services.
  • Act as the Single Point of Contact, providing Supplier Quality (SQ) support at Janssen Supply Chain (JSC) sites.
  • Document assessments of supplier quality systems for the supply chain by means of on-site audits, questionnaires, or other tools in order to proactively assure the quality and conformity of supplied materials.
  • Lead proactive quality initiatives with suppliers to identify and implement improvements regarding their performance, quality, and cost.
  • Assess the impact of reported quality deviations and changes on the status of the suppliers and materials and coordinate the required corrective actions.  Take part in the selection and qualification of new suppliers in cooperation with other departments.
  • Have involvement in change management, deviations, escalations, compliance issues, recalls, and field actions that are related to suppliers and external manufacturers and the materials they supply.
  • Establish and handle periodic review of Quality Agreements.
  • Establish and revise Qualification Statements, periodic performance metrics, and qualification classification for suppliers and API contract manufacturers.
  • Help in preparing internal sites and external manufacturers for health authority inspections. 


Qualifications
  • A minimum of a Bachelor’s degree (or equivalent degree) is required.
  • A degree focused in Engineering or Science is preferred.
  • A minimum of 8 years of relevant experience in a FDA or health authority regulated industry is required (Medical Devices, Pharmaceuticals, OTC/Consumer, etc.).
  • Must have strong Quality and Compliance experience in FDA regulated industry and knowledge of Quality Operations standards.
  • Strong knowledge of Change Control, Deviation Handling, and CAPA is required.
  • Must have auditing experience (can include either internal or external auditing); External auditing experience is preferred.
  • Must have experience working in highly cross functional environments, including experience interacting with the following areas: R&D, Operations, Procurement, Technical Operations, and Regulatory Affairs.
  • Experience handling the oversight of external suppliers and/or manufacturers is preferred.
  • Prior experience developing/maintaining Quality agreements is preferred.
  • Experience working with an Event Tracking System and an ERP (Enterprise Resource Planning) system is highly preferred; Experience working with SAP and/or TrackWise is a plus.  
  • Experience utilizing risk management strategies/tools in FDA regulated industry is preferred.
  • This position will be based at or work remotely near the following Janssen sites:  Athens, GA, Manati, Puerto Rico, or Vacaville, CA. Candidate must be willing to be located within commutable distance to one of these locations.
  • The position requires the incumbent to travel extensively within the North America primarily, but also occasionally to Latin America, Europe or Asia Pacific regions. This may amount to 40% of total work time. The ability to drive and to be comfortable with air travel are absolute requirements.


Primary Location
United States-Georgia-Athens
Other Locations
North America-United States-Puerto Rico-Manatí, North America-United States-California-Vacaville
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Assurance

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.