Snr. Manager, QA - Operations,Systems,Compliance - EU
Quality | Amsterdam, Netherlands | Full Time
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 recognise and kill tumours. Kite Europe is headquartered in Stockley Park, UK and is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs
We are seeking highly motivated individuals to join us as (Senior) Manager, Quality Assurance – Operations/Systems/Compliance 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.
The position is part of the European Technical Operations team that is located in Amsterdam, the Netherlands.
Key Responsibilities (include but are not limited to):
- Receipt and disposition of incoming materials (if applicable).
- 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.
- Oversee the product disposition 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.
- Maintain and report monitoring and control metrics for Quality Systems in support of the Management Review.
- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
- Develop and implement Quality on the floor processes, including batch record review.
- Schedule staff to support manufacturing/packaging processes in order to ensure on-time delivery of product to patients.
- Train, manage, and coach staff in the Amsterdam site.
- 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.
- Assist in EU site qualification program.
- Assist in global Supplier Quality Management program.
- Implement and maintain GMP training system in 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 collaboration amongst individuals
- Demonstrated ability to train, manage, and coach staff
- Good interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite Pharma is an equal opportunity employer with offices based in Amsterdam. Kite Pharma offers the opportunity to be part of a successful, fast-growing company in a cross-functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com.
No phone calls please and no agencies or recruiters.