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
- 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
- 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.
- A minimum of a Bachelor’s degree (or equivalent
degree) is required.
- A degree focused in Engineering or Science is
- A minimum of 8 years of relevant experience in a
FDA or health authority regulated industry is required (Medical Devices, Pharmaceuticals,
- Must have strong Quality and Compliance
experience in FDA regulated industry and knowledge of Quality Operations
- 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
- Must have experience working in highly cross
functional environments, including experience interacting with the following
areas: R&D, Operations, Procurement, Technical Operations, and Regulatory
- 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
United States-Georgia-AthensOther Locations
North America-United States-Puerto Rico-Manatí, North America-United States-California-VacavilleOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function