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J&J Family of Companies Director, External Quality- Large Molecule in Trenton, New Jersey

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, External Quality- Large Molecule ideally located in Horsham, PA or Titusville, NJ. May also consider other location in close proximity to a J&J site in New Jersey or Pennsylvania. Would consider other J&J US location including remote US location with travel to NJ or PA as needed.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we ae working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.

In this position you will direct a team of 5-7 quality professionals responsible for oversight of large molecule external manufacturers in North America, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product performance standards.

  • Direct all Quality and Compliance activities for External Manufacture of Large Molecule API and Parenteral Fill Finish sites in North America.

  • Develop objectives for External Quality Large Molecule Team in alignment with Global Quality and Janssen Supply Chain strategies.

  • Lead work team to deliver objectives with agility and patient focus, while encouraging a culture of innovative thinking and risk-based decision making.

  • Act as senior level partner, bridging external and internal supply chain sites, and working closely to identify new opportunities and tackle problems to meet business needs.

  • Partner with Product Management and Customer Management teams to ensure consistent supply to the markets.

  • Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.

  • Represent Quality in the selection, development and management of external partnerships.

  • Provide Quality leadership and support for tech transfer of new and legacy products.

  • Lead the overall development, implementation, and effective execution of quality systems in support of manufacture at external sites.

  • Ensure compliant delivery of clinical and commercial supplies in accordance with all applicable health authority regulations and J&J standards.

  • Support investigations, customer complaints, adverse trends, data collection and analysis, and reporting, as the need arises.

  • Escalate issues to Senior Management when appropriate.

  • Monitor trends, identify risk, recommend and implement appropriate mitigation actions.

  • Manage Health Authority Inspections of external sites, and work with local health authority as necessary.

  • Define the Quality Strategy and Strategic Account Plan for a portfolio of external manufacturing sites.

  • Influence and build relationships with internal and external partners to continuously improve quality culture and business excellence.

  • Supervise direct reports. Provide mentoring and coaching, development planning, and conduct performance reviews.

  • Travel to External Manufacturing sites to provide cGMP assistance and quality oversight

Qualifications

  • Bachelors Degree in engineering, science, or an equivalent technical field. Advanced degree is preferred.

  • A minimum of 10 years experience working in Quality, Technical Operations, Manufacturing and/or similar area within pharmaceuticals, biotech, or medical device industry is required

  • Experience in biologics manufacturing is required

  • Experience in providing cGMP compliance support, developing Quality Systems, and supporting Tech Transfers at External Manufacturers is required

  • Experience in communicating issues to all levels of the organization is required

  • Experience with quality oversight of clinical and/or commercial manufacturing operations is required

  • Experience in aseptic processing is required

  • Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production is required

  • Strong interpersonal and written/oral communication skills is required

  • Ability to quickly process complex information and make critical decisions with limited information is required

  • Proven experience with all dosage forms is preferred

  • Experience with vaccines is preferred

  • Experience investigating product quality complaints is preferred.

  • Proficient in applying process excellence tools and methodologies is preferred

  • Up to 30% domestic travel may be required

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

United States-Pennsylvania-Horsham-

Other Locations

United States, United States-New Jersey, United States-Pennsylvania, United States-New Jersey-Titusville

Organization

JANSSEN SUPPLY GROUP, LLC (6046)

Job Function

Quality

Requisition ID

2105883795W

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