Director, Product Quality Management-00000KNH
Description
Janssen Supply Group, LLC, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Director Product Quality Management, located in either Raritan, NJ; Titusville, NJ; Malvern, PA; Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; or Schaffhausen, Switzerland.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Product Quality (PQ) organization within the Janssen Supply Chain is responsible for the quality strategy and quality aspects of the Janssen R&D products to ensure that the medicines developed and supplied to our patients are efficacious and safe. In close partnership with the development and new product launch teams the PQ organization is instrumental in developing and/or translating creative and innovative compliant approaches to introduce new products.
The Product Quality group is instrumental in ensuring right first time and first pass approval to allow uninterrupted supply to patients while laying the foundation to achieve compliance with the international regulatory standards demanded in a global marketplace.
This effort is supported by a team of Product Quality Leaders / Directors to oversee all aspects of product development.
The Director Product Quality Management serves as a Quality Single Point of Contact in the CMC development and the Supply Chain New Product Launch teams for the molecules/products assigned. Establishes and develops strong working relationships within and across the Supply Chain, the development organizations and as needed across other Johnson & Johnson sectors. Serves as global resource to the entire Quality organization to provide guidance, training and consultation on new product development. Represents Product Quality in a leadership role on various multidisciplinary project teams, committees and special projects as assigned. Serves as champion for key strategic products. Lead and mentor the Quality sub-team for the products assigned. Product Quality Leaders / Directors will be accountable for the Product Control strategy for each of the products they are responsible for. Remains current in knowledge, skills and industry trends; trains on new regulations, guidelines, procedures and processes. Makes a positive contribution by making suggestions for improvement.
Qualifications
A minimum of a Masters Degree or equivalent professional experience required in pharmaceutical, chemical, or biological sciences. A minimum of 15 years of experience in the pharmaceutical and/or biotechnology industry is preferred. 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. Identifies and provides balanced management of quality and compliance risks with business needs. 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. Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Advanced knowledge and experience in New Product & Process Development required. Experience with regulatory inspections and preparedness 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. Approximately 10-25% travel domestic and international is required.
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J2W:LI NA
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:Asia Pacific-India, North America-United States-Pennsylvania-Malvern, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality (Generalist)
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