Director, Quality Control - EUNetherlands - AmsterdamQualityRegular
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 are seeking a highly motivated individual for the role of Director Quality Control to work in this exciting new area of cancer immunotherapy. In this role, you will continue to build the EU QC team and implement and manage Kite Pharma Quality Control in Kite Pharma EU. You will collaborate closely with other Kite manufacturing sites around the globe and manage tech transfer and validation of QC Analytical and Microbiological assays to TCF04. Next to that you will be a member of the Global QC Steering Committee. This position will report to the Executive Director, Quality Site Head of TCF04. The role will be based at our commercial cell therapy site in Hoofddorp, NL.
The Director, Quality Control - EU will provide oversight for analytical and micro methods of commercial and clinical stage manufacturing of final drug product. Responsible for phase appropriate validation of bioanalytical methods oversight and management. Responsible for in-process, final product testing, Incoming Goods including Apheresis Accession and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. Work with outside testing labs and other Kite sites for method transfers. Accountable for managing the QC Micro, Incoming Goods testing, and QC Analytical group, its people, projects and timelines.
- Lead the QC Analytical, Incoming Goods, Services and Micro team to sustain a scalable group to support the S&OP and multiple clinical programs.
- Responsible for talent management including recruitment, selection, development, training & retention of QC staff at the site and ensures that proper technical and quality skill sets and competencies are consistent with business and technology plans
- Represent QC in regulatory inspections and Interact with Regulatory agencies and participate in Inspections.
- Review of records, generation and approval of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Responsible for QC’s training. Monitor the GMP systems currently in place to ensure compliance with documented policies
- Oversight on transfer and validation of analytical and micro methods from US commercial QC laboratories and for clinical stage product from Analytical Development to the EU Amsterdam QC site as well as the transfer and validation of methods to OTL or other sites. Validation of methods will be phase appropriate.
- Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.
- Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary. Provide updates at appropriate meetings.
- Oversight on Quality Indicator status, ensure timely closure of lab investigations, deviations, and change controls
- Responsible for Data trending, control charts and metrics.
- Perform duties as needed
- PhD molecular biologist or biochemist preferred with 5-7 years of Quality Control management experience or MS with 8-10 years of Quality Control management experience.
- Candidate should be well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
- The ideal candidate has a strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, UV, Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of cellular therapy products
- Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
- Proficient in application of QC principles, concepts, Industry best practices and standards
- Full working knowledge of cGMPs, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the Pharmaceutical Industry
- Understanding of aseptic manufacturing and of USP/BP/JP and EP pharmacopoeias.
- Proven analytical and conceptual skills
- Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to develop, coach, and mentor key employees
- Strong organizational, planning and problem solving skills. Able to manage competing priorities creating an effective team environment
- Hands-on, roll up your sleeves mentality
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Able to influence without authority.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities