Manager, EQ Small Molecules

Johnson and Johnson

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Janssen Supply Group, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Manager, External Quality (Small Molecules)! This position can be performed remotely anywhere within the United States, Puerto Rico, and Canada.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are 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 Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

In this position you will provide end to end quality oversight for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

Key Responsibilities:

  • Provide quality leadership and technical support to ensure effective execution of quality systems at external manufacturing sites
  • Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
  • Support the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
  • Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.
  • Monitor quality performance through the development of key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
  • Build relationships with internal and external partners to meet patient supply requirements.
  • Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
  • Collaborate with external manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments.
  • Provide oversight for tech transfer and new product introduction activities.
  • Support risk management initiatives necessary to improve performance.

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