Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As Qualified Person you’ll be joining a newly formed team in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity.
You’ll be reporting to the Director Qualified Person.
In this role, you will develop, implement and overview the process for product disposition within the EU.
Your responsibilities, among others, will be:
- Develop and implement Kite Qualified Person (QP) process for product disposition within the EU member, Switzerland, Israel,…etc countries (per EU Directives 2001/20/EC and 2001/83/EC).
- Disposition and involve in issue resolution related to manufacturing and testing of vectors and final product from US and European sites to EU destination.
- Support site QA head in the implementation of Supplier Quality oversight program in EU. QP must be involved in all critical suppliers, including contract manufacturers and contract test laboratories.
- Ensure that the marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned.
- Support site QA head in setting up a robust Quality Management System for Kite in EU, meeting EU standards, in line with and leveraging from the Kite US QMS. The objective is to obtain a GMP license for the Kite new building for its EU GMP activities.
- Review all submissions (CMC) to regulatory authorities concerning the product (IMP/MP).
- Build relationships with all other functional teams within Kite, particularly with the QPPV in EU (and counterpart in US) to ensure smooth implementation and maintenance of the Pharmacovigilance system in EU (Eudralex volume 9b).
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Bachelor’s / Master degree in biological sciences or related field.
- Registered QP in The Netherlands, experienced in the disposition of biologic products for clinical and /or commercial use, preferably ATMP’s.
- Minimum of 3 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
- Experience auditing CMOs, Contract testing labs and/or CROs.
- Experience with direct European Health authority inspections and interactions
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Ability to travel up to 20%.
- Ability to be flexible with schedule, and work overtime as needed
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.
Only candidates in possession of a valid EU work permit will be considered.
Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.