Description

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

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  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 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.

Qualifications

Qualifications

Required:

• Master’s degree in Pharmacy, Biochemistry, Biology or equivalent education.
• Previously registered as a Qualified Person.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical industry.
• A minimum of 6 years working in an EMA/FDA regulated environment.
• Ability to work with cross-functional teams and to drive collaboration in a fast-paced environment.
• Ability to work within a digitalized environment.
• Good influence skills and customer centered.
• Strong interpersonal and written/oral communication skills.
• Empowered professional who can make well motivated pragmatic decisions on their own.
• Ability to lead the resolution of complex Quality and Compliance issues.

Preferred:

• Experience in Biologics products and/or aseptic manufacturing.

Other:

• Full-time position (5 days a week).
• An extensive on-the job training program will be provided before QP responsibilities are transferred.
• Must be proficient in English language (Speak, Read & Write)

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.