Senior Manager External Quality Advanced Therapies

Janssen Supply Group is recruiting for a Senior Manager External Quality - Advanced Therapies, located in Horsham, PA and Titusville, NJ.

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.

Janssen Supply Group is recruiting for a Senior Manager External Quality - Advanced Therapies. In this position you will lead the quality oversight for specified external manufacturers of CAR-T products, ensuring consistent delivery of pharmaceutical products from the external manufacturer that meet all required safety, regulatory compliance, and product quality standards.

You will provide QA support for technology transfer, External Manufacturer (EM) qualification, manufacturing and release and improvement of manufacturing processes. You will monitor quality performance of the external CAR-T manufacturer, proactively identify risks and lead improvement programs to mitigate. This position will lead a work team, located on-site as well as remote, that is responsible for delivering the site quality goals.

Key Responsibilities:

• Provide quality leadership and technical support to ensure effective and compliant execution of quality systems at external manufacturing sites
• Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
• Daily management and coordination of the EQ work team supporting the EM as needed
• Lead 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
• Supervise 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; Influence external manufacturers to continuously improve processes and procedures passionate about reliability, execution, and quality culture
• Collaborate with External Manufacturers to support health authority inspections; supervise and follow-up on associated response and commitments
• Provide oversight for tech transfer and new product introduction activities; lead PAI readiness activities, and support associated health authority filings and approvals
• Partner with External Manufacturing sites to define the quality strategy through benchmarking and knowledge sharing.
• Lead risk management initiatives vital to improve performance
• Partner with key internal stakeholders in support of supply chain to meet patient supply requirements
• Assess current quality systems and recommend improvements to improve compliance and optimize processes