Roman Alcocer
Sr Gcp Pv Glp Qa Manager @Exelixis
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WORK HISTORY
Sr Gcp Pv Glp Qa Manager @Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics- Accountable for assisting development, implementation and maintenance of end-to-end QA systems and activities for GCP/GLP/PV operations, including planning and conducting vendor audits, and associated documentation activities- As QA Core, supports clinical studies as QA Partner. Ensures rapid escalation and issue resolution- Responsible for developing, tracking and managing periodic management reports including key GCP/PV/GLP compliance and QA metrics- Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented- Supports, trains internal staff and oversees GCP/PV/GLP consultant
EDUCATION
Montgomery High School
Alumnus
UC Santa Barbara
Mathematics, B.S.
Santa Rosa Junior College
Economics
ABOUT ROMAN ALCOCER
Solving problems by thinking in systems. From product management software to…
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