Janssen Supply Group, LLC is currently recruiting for a Director, Product Quality Management (Quality Integrator) to be based at one of the following sites: Cork, Ireland; Leiden, Netherland; Geel, Belgium or Beerse, 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 Director, Product Quality Management (Quality Integrator) will:
- Have end-to-end accountability for the quality strategy and quality aspects for new products from Early Development through Commercialization for an assigned portfolio of products.
- Develop and lead the quality and regulatory strategies to support new platforms that are in licensed or developed within the Janssen Supply Chain or other J&J operating companies.
- Develop and/or translate creative and innovative compliant approaches to introduce new products that are introduced right the first time and result in first-pass approval.
- Help resolve issues and facilitates the timely advancement of new products to ensure they are filed and launched on time.
- Serve as the global resource to the entire Quality Organization to provide guidance, training and consultation on new product development.
- Coordinate compliance with the GMP, EHS and SOX requirements and guidelines, as applicable.
- Represent Global Quality on the CMC and New Product (NPT) Teams.
- Serve as the single point of Global Quality contact.
- Represent Product Quality Management (PQM) in a leadership role in various multidisciplinary project teams, committees and special projects as assigned.
- Be the Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI audits for the product assigned.
- Define and oversee the necessary QA resource for global and local QA of his or her assigned products.
- Support QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
- Ensure standard Global Quality new product introduction processes and norms are current, used across sites and facilitates communication throughout Global Quality.
- Participate in product safety management teams to present Product Quality Complaints trends and topics.
- Gives input to the development of new strategies and implements and deploys strategies.
- Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production.
- These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
- Provides Quality structure, direction and decision making to the teams (Quality, CMC and NP Team) in situations of high risk, uncertainty and ambiguity.
- A minimum of a Bachelor’s Degree (or equivalent degree) is required.
- An advanced degree (M.S., etc.) focused in pharmaceutical, chemical, or biological sciences is preferred.
- A minimum of 10 years’ experience in the Pharmaceutical, Biotechnology, OTC, and/or Medical Device industry is required.
- Global health authority regulatory submission experience/Regulatory filings: questions and responses is required.
- Leadership of a Global Team and proven track record in leading multifunctional ‘virtual’ teams to success is required.
- Experience identifying and providing balanced management of quality and compliance risks with business needs is required.
- Knowledge of domestic and international GMP required.
- Knowledge of Product Manufacturing Processes (Drug Substance/Drug product) in Biotech and/or Pharma required, particularly in technology transfer.
- Prior experience working with large molecule manufacturing is highly preferred.
- Advanced knowledge and experience in New Product & Process Development is required.
- Experience with regulatory inspections and preparedness is required.
- Relationship building, partnering and influencing in a matrix organization is required.
- Ability to provide strategic leadership to meet business objectives in a highly dynamic business environment is required.
- 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 or Beerse, Belguim; Schaffhausen, Switzerland; Raritan, NJ; Spring House, PA or Malvern, PA.
United States-New Jersey-RaritanOther Locations
Europe/Middle East/Africa-Belgium-Antwerp-Geel, North America-United States-Pennsylvania-Malvern, 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-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function
Quality (Generalist)Requisition ID