Jose Arrastia

Associate Director, Quality Systems @Novartis Gene Therapies

San Diego, CA, US

Successfully led Novartis San Diego site on various integration projects including migration to a new Learning Management System (LMS) and two new (2) Electronic Document Management Systems (EDMS). • San Diego site Key User for a newly implemented TrackWise QMS system (AQWA-Q) for the management of deviations, investigations Quality Events. • As leader, provided strategic site quality system design and collaborated with manufacturing operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice. • Led and managed the San Diego site document control group and the GxP training group daily activities. • SOP/Document Management: Managed approval of all instruction sets, specifications, sampling instructions, test methods and other quality control procedures directly related to operations and other cGMP activities. • Training: Ensured all personnel, including contractors, consultants and temporary employees had the proper qualifications, skill sets, education, and training to perform the job in accordance with applicable procedures and regulations.

California State University, Long Beach

Bachelor of Science (BS), Microbiology

University of La Verne

Master of Science (MS), Leadership and Management

Project Management Academy

PMP coursework