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San Diego, CA (54)
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Fate Therapeutics, Inc. (5)
MEI Pharma, Inc. (4)
Chambers Group Inc (3)
Turning Point Therapeutics, Inc. (3)
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Establish the vision and implement the associated strategy for the clinical Quality Assurance function within Sorrento Therapeutics.
Develop the CQA plans for Phase I-III trials and implemented the actions necessary for global clinical sites to comply with Gossamer’s SOPs, study protocol, and country, federal, state, and local regu...
Experience in implementation of an Enterprise Resource Planning (ERP) solution, electronic Document Management System (eDMS), electronic Learning Management System (eLMS), electronic CAPA solutions an...
Directs development of plans, guidelines, policies and processes, to ensure the achievement of quality targets. Develops and leads implementation of organization projects and processes to ensure overa...
Drives quality improvement processes to ensure on-going reductions in Cost of Poor Quality (COPQ) and escapes. Directs collection and analysis of quality information from multiple sources to develop l...
Dispositions drug substance\drug product batches and work-in-process materials for use in downstream manufacturing operations, dispositions final products for clinical or commercial use. Provides appr...
Accountability for achievement of published membership quota per quarter, Direct responsibility for following up on new leads and referrals resulting from multiple lead sources. Ensure operators meet...
Provides functional expertise for Clin Ops strategies and tactical implementation of the studies by managing timelines, deliverables, budget forecasting, etc. Align with the VP of Clinical Operations...
Help to maintain a comprehensive privacy program for GDPR, HIPAA and CCPA including driving privacy impact process, incident communication plan and privacy tabletop exercise, Contribute to and maintai...
Manage and oversee the implement of the formulation and process development and optimization, clinical supply and registration batch manufacturing, and validation activities at external contract devel...
Continually researches grants, projects and proposal availability as department staff identifies possible opportunities, and develops and implements presentations including pre-proposal and grant pape...