For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
We are seeking highly motivated individuals to join us as Manager, Quality Assurance Operations in the EU. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross-functionally to assist with the development, implementation and maintenance of a quality system that supports Kite’s rapid expansion of our first commercially marketed cell therapy product in the EU.
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.
The position is part of the Kite EU Quality Assurance Operations team that is located in Hoofddorp, the Netherlands. As Manager Quality Assurance 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 will be reporting to the Associate Director Quality Assurance.
Key Responsibilities (include but are not limited to):
- Lead all aspects of manufacturing processes and provide guidance and advice to manufacturing personnel
- Train, lead, and coach staff in the Hoofddorp site.
- Develop and implement Quality on the floor processes, including batch record review.
- Schedule staff to support manufacturing/packaging/ distribution processes in order to ensure on-time delivery of product to patients.
- Receipt and disposition of incoming materials.
- Review batch-related documentation, and ensures resolution of issues to release product.
- Perform preparations for product disposition/lot closure by the Kite QP.
- Oversee the packaging and shipping process for EU.
- Ensure all product-related Deviations are initiated, investigated and resolved. Ensures that associated CAPAs are initiated and resolved, as needed.
- Maintain and report metrics related to batch record review and product disposition in support of the Management Review.
- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Intake of product complaints for EU and/or related investigations.
- Liaise with other Kite manufacturing sites, supply chain and CMO’s, where applicable to facilitate smooth batch release for EU.
- Liaise with corporate quality and other Kite quality groups to develop, implement and maintain global quality systems as well as site-specific quality systems (GMP) in the EU.
- Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
- Perform other duties as assigned.
- Bachelor’s degree in the biological sciences or related field.
- Minimum of 7 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
- Minimum of 4 years of management/leadership experience
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to effectively negotiate and build teamwork amongst individuals
- Proven ability to train, manage, and coach staff
- Good interpersonal, verbal and written communication skills
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
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.
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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Equal 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 individual’s 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 log onto your Internal Career Site to apply for this job.