Qualified Person

Join Kite in advancing cancer therapies and helping shape the future of medical science. As a Qualified Person, you’ll be joining a team in which people of diverse backgrounds and experiences strive to present as One QP voice to the organization. You demonstrate the ability to make well-considered decisions while collaborating effectively within a multicultural team environment, consistently upholding and adhering to the company’s values. You will report to the Head of EU QPs.

Job Description

Your responsibilities

In this role, you will perform batch certification processes within the EU and other countries that are supplied from our facility in Hoofddorp, the Netherlands. In addition, you will support projects and share your expertise and experience with other functions in the organization.

• Perform EU QP batch certification by ensuring that the Marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned, in accordance with EU Directives 2001/20/EC and 2001/83/EC.
• Participate in projects.
• Build relationships with all other functional teams within Kite and Gilead affiliates across the globe.
• Share knowledge with others in the organization.
• Ensure our reliance on the Pharmaceutical Quality System is well founded.
• Participate in the internal audit program and global site audit.
• Support and participate in inspection readiness plans and interact with regulatory agencies during inspections as needed.

Your experience

• You have a Bachelor’s or Master’s degree in Pharmaceutical Sciences or a related field.
• You have ideally 10 years of progressive, relevant experience in a pharmaceutical, biotech, or biologics operation (QA, QC, manufacturing), of which ideally 5+ years are as a registered QP in the Netherlands.
• You have experience in the disposition of sterile products for clinical and/or commercial use, including small molecules, biologicals and/or ATMPs.
• You have experience writing, evaluating, and closing investigations, CAPAs, and change control records.
• You have previously performed audits, including internal audits or external audits such as CMOs and contract testing labs.
• You have been in direct contact with European Health Authority inspections and interactions.
• You show in-depth knowledge of and ability to apply GMP in conformance with US, EU, and ROW standards.

Your profile

• You have excellent interpersonal, verbal, and written communication skills essential for this collaborative work environment.
• You have demonstrated experience in stakeholder management within a global, multicultural pharmaceutical organization.
• You engage effectively with a diverse range of stakeholders across different levels and backgrounds, fostering an inclusive and collaborative environment.
• You demonstrate strong situational awareness, with the ability to accurately interpret group dynamics, adapt to the context, and engage with confidence and composure.
• You demonstrate a strong team-oriented mindset, combining humility, ambition, and emotional intelligence to collaborate effectively with others.
• You are efficient with your time management, while flexible to change your priorities based on team and company needs.
• You are self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the job description.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies. The company focuses on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors.