Janssen Supply Group, LLC is currently recruiting for a Senior
Manager, Product Quality Management, Quality Integrator to be based at one of
the following sites: Cork, Ireland; Leiden, Netherland; Geel, Belgium; Schaffhausen, Switzerland; Raritan,
NJ; Spring House, PA or Malvern, PA.
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.
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. Please visit
www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
The Senior Manager, Product Quality Management, Quality Integrator
- Represent Global Quality on the CMC and New Product integration
- Serve as liaison between NPT and Analytical group and act as the
single point of Global Quality contact.
- Assure Quality milestones and Quality stage gate deliverables are
- Be the Quality reviewer of health authority submissions (i.e.,
BLA, NDA, MAA) and associated HA (Health Authority) questions on the filings.
- Approve filings and questions for secondary filings.
- Define and oversee the necessary QA resource for global and local
QA of his or her assigned products.
- Lead a comprehensive Quality new product integration team that
assures Quality throughout clinical, DS (Drug Substance), DP (Drug
Product), FF (Fill/Finish), & Device development through launch.
- Ensure standard Global Quality new product introduction processes
and norms are used across sites and facilitate communication throughout Global
- Maintain the flow of communications between Global Quality and the
CMC and NP Teams.
- Present project updates to QM for Global Quality alignment in
advance of Stage Gates.
- A minimum of a Bachelor’s Degree or equivalent degree is required
- A minimum of 8 years’ experience in the Pharmaceutical, Biotechnology,
OTC, and/or Medical Device industry is required
- In-depth knowledge in cGMP, standards, policies and procedures
- Knowledge of domestic and international GMP preferred
- Knowledge of Biotech and/or Pharmaceutical manufacturing is required
- Experience with technology transfer is preferred
- Large molecule experience is preferred
- Experience in Product & Process Development is a plus
- Experience with Quality Systems is preferred
- Experience with Quality content of Regulatory filings is preferred
- Experience with regulatory inspections and preparedness is
- This position may require between 10-25% travel depending on
business needs and will be located at one of the following sites: Cork,
Ireland; Leiden, Netherland; Geel, Belgium; Schaffhausen, Switzerland; Raritan, NJ; Spring House, PA or
United States-New Jersey-RaritanOther Locations
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Belgium-Antwerp-Geel, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Netherlands-South Holland-LeidenOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function
Quality (Generalist)Requisition ID