Qualified Person

Janssen Supply Group is recruiting for a Qualified Person External Quality – Advanced Therapies, located in The Netherlands

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 Qualified Person Advanced Therapies. In this position you will contribute to setup and will complete the commercial release process to the European Union of vaccines and cell therapy (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 work in close collaboration with other teams by providing QP support for technology transfer, External Manufacturer (EM) qualification, manufacturing, and product release as well as improvement of quality and manufacturing processes. This team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.

Key Responsibilities:

• Act as EQ Qualified Person for Advanced Therapy products
• For vaccines, support the process related to the EU Official Control Authority Batch Release and Marketing Information Forms, as applicable
• For CAR-T, approve exceptional administration of Out of Specification batches and notify Health Authorities as applicable
• Approve change controls, deviations, and non- conformities for Janssen vaccine products as necessary
• Maintain end-to-end quality oversight of the supply chain for vaccine products released by Janssen Biologics.
• Escalate significant issues to senior leadership and provide input on decisions related to health authority communications and field actions
• Partners with other quality associates form External Quality (e.g Centralized batch release team, Account owners) to continuously improve the batch certification and release process for New Modality products (e.g., vaccines and cell therapy).
• Provide QP support for tech transfer and new product introduction activities; support PAI readiness activities and associated health authority filings and approvals
• Support regulatory inspections at both internal and external manufacturing sites when necessary, including direct interactions with regulatory inspectors.
• Serve as point of contact and subject matter authority within the QA organization for quality related projects and issue management.
• Partner with key supporting functions including PQM, Compliance, regulatory, and internal Site QA, to ensure all activities within external manufacturing are carried out in compliance with corporate, cGMP and other regulatory requirements, passionate about reliability, execution, and quality culture
• Pro-actively identify risks and potential issues and lead resolution.
• Perform related duties as assigned by supervisor
• Maintain compliance with all company policies and procedures
• Acts as Deputy of EQ QP Advanced Therapies Director as the need arises