J&J Family of Companies Senior Manager, Product Quality Management, Quality Owner in Geel, Belgium
Janssen Supply Group, LLC is currently recruiting for a Senior Manager, Product Quality Management, Quality Owner, 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 Owner will:
Represent Global Quality on the CMC and New Product integration team (NPT).
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 achieved.
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 Quality.
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 required
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 preferred
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 Malvern, PA
United States-New Jersey-Raritan
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Geel, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-Pennsylvania-Malvern
JANSSEN SUPPLY GROUP, LLC (6046)