Qualified Person for Large Molecules

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Qualified Person for Large Molecules

Janssen Supply Group, a member of the Johnson & Johnson Family of companies, is recruiting for a Qualified Person for Large Molecules, 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  https://www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group is part of the Janssen Pharmaceutical Companies

Position overview

• The Qualified Person for Large Molecules is an integral member of the External Quality (EQ) team responsible for overall quality oversight and governance of Large Molecules’ external manufacturers.
• The person in this position acts as one of the Qualified Persons (QP) releasing Large Molecules commercial products from internal and external manufacturers to markets worldwide (except US), on behalf of Janssen Biologics https://B.V. (Leiden, The Netherlands).
• This person has extensive knowledge of the regulatory requirements for QP certification of medicinal products, work in close collaboration with cross-functional teams and contribute to the overall development, implementation, execution, and improvement of quality systems of pharmaceutical Large Molecule products. 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.
• The Qualified Person for Large Molecules demonstrates ability to take ownership for and lead the resolution of Quality and Compliance issues related to batch release.
• This is a full-time position (5 days a week), and it does not require travel to other sites on a regular basis.

Tasks & Responsibilities

• Act as Qualified Person for Large Molecules commercial medicinal products.
• Review and approve change controls, deviations, and non- conformities, as necessary.
• Maintain end-to-end quality oversight of the supply chain for Large Molecules released by Janssen Biologics in Leiden (The Netherlands).
• Pro-actively identify risks and potential issues and lead resolution.
• Escalate significant issues to senior leadership and provide input on decisions related to health authority communications and field actions.
• Partners with other quality associates to continuously improve the batch certification and release process for Large Molecules products.
• Provide QP support for new product introduction activities, support inspection readiness activities and associated health authority filings and approvals.
• Support regulatory inspections at both internal and external manufacturing sites when necessary.
• Serve as point of contact and subject matter within the Quality Assurance organization for quality related projects and issue management.
• Partner with key supporting functions, including Product Quality Management, Compliance, Regulatory, and internal Site Quality Assurance, to ensure that activities are in compliance with cGMP and other regulatory requirements.
• Perform related duties as assigned by Supervisor.
• Maintain compliance with all company policies and procedures.
• Acts as Deputy of the Sr Manager and QP Team Lead as the need arises.