Jason Turk Email and Phone Number

• Defined and guided the overall computer system lifecycle approach by providing global leadership and subject matter expertise for all aspects of quality, validation strategy, and change and configuration management of enterprise and local applications across the organization.• Worked cross-functionally and across sites with IT, Quality, and business process stakeholder teams to evaluate risk, define qualification and validation requirements, and lead implementation of global enterprise and site-based automated systems.• Key member of multiple steering and leadership teams with responsibility to collaborate, influence, and guide stakeholders to develop data landscape vision and identify systems and processes necessary to progress from clinical stage toward commercial cell therapy manufacturing.• Participated and reported on progress to a cross-functional program and portfolio team tracking to business objectives and timelines.• Developed and implemented data integrity program. • Led implementation of a solution to digitally manage the complete commissioning, qualification, and validation life cycle, increasing quality through automation and reducing cycle time nearly 50%.

• Served as Validation lead in the implementation of multiple enterprise and local computer systems, ensuring implementation strategies and deliverables are applicable, technically sound, and in accordance with company procedures and objectives.• Shaped company computer system validation and change procedures.• Created templates for validation deliverables including user and functional requirements, design and configuration specifications, IQ/OQ/PQ/CQ protocols, risk assessment, traceability matrix, validation plan, validation report, and periodic review.

• Took ownership of key validation deliverables in support of successful implementation of electronic batch record (EBR) utilizing a Manufacturing Execution System (MES), resulting in over 40% reduction of batch record size while reducing error and potential contamination during manufacturing. • Entered a highly dynamic project and team, quickly integrating with company’s existing validation strategy and risk-based approach to drive the project to successful completion by ensuring immediate and long-term project milestones were met.• Served as Quality Engineering lead in creation, review, and/or approval of all validation deliverables for secondary phases of EBR project, and facilitated completion of activities with multiple company stakeholders, including IT, logistics, QA, manufacturing, and project management during these phases.• Collaborated with leads at multiple sites to define global computer system and equipment validation plans and improve risk-based assessment, commissioning, qualification, validation, and maintenance procedures and deliverables.

Brooks Life Sciences is the leading worldwide provider of innovative and comprehensive sample lifecycle management solutions for the life sciences industry. Brooks Life Sciences supports and advances the research, pre-clinical and clinical scientific community with its highly-flexible and fully comprehensive sample management storage solutions, instruments, devices, and consumables. Customers experience best-in-class solutions for automated storage systems for compounds and biospecimens, biorepository and biobanking services, pre-clinical and clinical sample storage consumables and instruments, cell therapy cryopreservation and cold chain solutions, to global sample preparation and analytical lab services.

Pacific Bio-Material Management, Inc. (PBMMI) has two divisions, Pacific Scientific Transport and Pacific Bio-Storage, both known within the life sciences industry. The primary focus is cold chain management - assisting with the storage, transport, management, and cold chain logistics of biological materials. PBMMI is a value added resource for our partners in biotech, pharma and research institutions.• Oversaw quality program across multiple sites in California and New York.• Designed, implemented, and actively managed a robust, comprehensive, cGMP compliant validation program which significantly broadened client base and increased revenue.• Developed protocols for proper storage and distribution of cell therapy, tissue, and various other pre-clinical, intermediate, and final products, and managed Deviations, CAPAs, SCARs, etc. related to products. • Created, executed, and reported packaging and shipping validations for a CAR T-cell therapy leader with FDA approved therapies, directly supporting their first BLA submission and approval. • Created and lead quality plan to replace the QMS at acquired sites with a global Brooks Life Sciences QMS, with extra emphasis in becoming ISO 9001:2015 complaint.• Interfaced with client auditors and global regulatory inspectors, and implemented CAPA as applicable.• Scheduled and conducted internal and supplier quality audits to monitor corporate objectives, reduce waste, lower costs, engage staff, and improve processes.• Provided project management and consulting services for leading pharmaceutical and healthcare companies.• Effectively communicated key performance indicators to executive/senior management and subsequently implemented improvement initiatives.

National Genetics Institute (NGI), provides advanced genetic testing services for blood screening, medical testing, and clinical research. NGI offers industry leading assays for human immunodeficiency virus (HIV), hepatitis A, B, and C (HAV, HBV, and HCV) viruses, and other infectious agents and has pioneered robust, sensitive, and high throughput methods for pooled specimen nucleic acid testing. NGI is licensed as a clinical laboratory provider by both state and federal agencies, and holds active Biologics Licenses from the US Food and Drug Administration (FDA) for screening of plasma for blood borne infectious agents.• Played instrumental role in obtaining FDA biologics licenses, clinical laboratory licenses and permits, CLIA certification, CAP accreditation, and GMP compliance for numerous state and regulatory agencies.• Oversaw equipment and computer system qualifications, including writing and/or revising protocols, tracking execution status, and assembling, reviewing, and approving validation reports.• Advised and trained other department personnel on the performance and reporting of validations, studies, etc.• Created clear and simple validation and study protocol and report templates that proved to produce consistent, accurate, logical, and reader-friendly documents.• Managed change control system covering creation and revision of SOPs and forms, validation and study protocols, databases, material specifications, interdepartmental projects, etc.• Designed and validated electronic controlled change, audit, and trend tracking tools which dramatically improved the ability to monitor ongoing activities, replacing overly complicated and complex manual processes.• Participated in external client audits and global regulatory agency and health authority inspections. • Conducted internal compliance and vendor audits, issued audit reports, and conducted follow-up activities.• Improved risk assessment tools and procedures and promoted their application.

• Developed new assays and researched ways to improve the performance of existing assays. • Developed and maintained project plans that accurately define objectives, scope and time frames.• Performed numerous clinical studies/trials, stability studies, process validations, and investigations.

• Processed a high volume of samples, screening for multiple viruses, using FDA licensed Polymerase Chain Reaction (PCR) assays.• Certified Trainer for instruction and evaluation of new employees.• Active role in determining and improving training guidelines.