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DESCRIPTION:

Janssen Supply Group, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Sr. Specialist, External Quality (Small Molecules)! This position can be performed at Titusville, NJ, Horsham, PA, Athens, GA, or Tampa, FL.
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 support for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

EDUCATION:

• A minimum of a Bachelor’s or equivalent University degree is required with a focus in life science, engineering, physical science preferred.

• Provide quality and technical support to ensure effective execution of quality systems at external manufacturing sites.
• Support the identification and resolution of quality issues and complaints, including review and approval of non-conformances and development of robust CAPA plans. Support the escalation and issue management processes.
• Review and approve quality systems documentation, including batch documentation and product disposition, change controls, manufacturing instructions, quality agreements, specifications, validation documentation, and technical studies.
• Monitor quality performance through 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. Support risk management initiatives necessary to improve performance. Write and implement quality procedures and work instructions.
• Collaborate to support health authority inspections and audits; monitor and follow-up on associated responses and commitments.
• Provide quality oversight for tech transfer and new product introduction activities. Support a variety of projects both internally and with external manufacturers.
• Act as a backup to External Quality account owners in support of external manufacturers as needed.