QA Manager Site QualificationNetherlands - HoofddorpQualityRegular
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. Our 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.
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 QA Manager Site Qualification you will be supporting our efforts in the exciting area of CAR-T cell therapy. You will work cross functionally and as part of a global team to assist with the qualification and monitoring program for apheresis centers and treatment sites (ACTS) who are already working or intend to work with Kite CAR-T cell products. In addition, as required, you will be responsible for performing and addressing quality systems aspects related to qualification and monitoring of ACTS.
- Perform new site qualifications (including audits and trainings) and monitoring of authorized ACTS
- Facilitate the review and approval of Quality Agreements, between Kite and the treating hospital
- Collaborate with cross-functional departments to ensure timely implementation of quality records
- Provide support to Kite CAPAs, OOS, deviations, change records, and product complaints. Interact with ACE (Australia, Canada and Europe) regional quality, local affiliates and treating hospitals as it pertains to issue resolution and or general questions
- Works cross-functionally within Kite (Supply Chain, Process Sciences, Manufacturing, Regulatory Affairs, Manufacturing Site Quality Assurance and Quality Control teams and Kite corporate quality) and externally, to assure compliance and strong relationships with treatment centers
- Assist with resolution of ACTS issues and discrepancies, and the investigations to resolve the issues
- Assist on the quality aspects of the implementation of an Apheresis Collection Application System in the ACE region as needed
- Collaborate with our Gilead affiliates in the routine management of the ACTS relationships
- Support inspection readiness plans and interact with regulatory agencies during inspections on ACTS-related and quality matters, as needed
- Liaise Kite quality teams to develop, implement and maintain ACE and global quality systems
- Assist as needed on the activation and maintenance of ACTS in Kite GMP IT systems
- Perform other duties as assigned
We are seeking a highly motivated individual which likes to join our international Site Qualification Team. The ideal candidate for this position is flexible, has great communication skills and feels comfortable in a fast-paced environment.
- Bachelor’s degree or higher in biological sciences, nursing, medical technologist, or related field
- Knowledge of GMP and quality assurance
- Proficiency in English
- Experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Team player
- Comfortable in a fast-paced company environment 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 nationally and internationally up to 40%
- Medical center or pharmaceutical auditing experience preferred
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred
- Proficiency level in more languages is a plus
- Previous experience presenting and responding to regulatory agency or certification audits, preferred
- Previous experience with managing supply and quality contracts with hospitals
- Proficient in MS Word, Excel, and Power Point
- Relevant experience working in multicultural and cross functional teams