Qualified Person

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

As a Qualified Person youll 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 companys values. You will report to the Head of EU QPs.

Your responsibilities

In this role you will perform batch certification process within the EU and other countries that are supplied from our facility in Hoofddorp the addition you will support projects. Additionally youre sharing your expertise & 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 (per 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 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 Bachelors / Master degree in Pharmaceutical sciences or 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 as a registered QP in the Netherlands.

• You have experience in the disposition of sterile products for clinical and /or commercial use (small molecules biologicals and/or ATMPs) writing evaluating and closing investigations CAPAs and change control records.

• You have previously performed audits (internal audits or external like CMOs and Contract testing labs) and have been in direct contact with direct European Health authority inspections and interactions.

• You show in-depth knowledge of and ability to apply GMP in conformance to US EU and ROW standards.

Your profile:

• You have excellent interpersonal verbal and written communication skills are essential in 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.

• Demonstrates 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 job description.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.