- Insight Global (San Francisco, CA)
- …* Ensure computerized systems and software used in support of manufacturing, quality management, and other GxP activities are developed, validated and maintained in ... FDA, EU and other international regulations and ISO standards. * Support quality risk assessment activities (eg, system level risk assessment, functional risk… more
- Genentech (Oceanside, CA)
- …periodic reviews, manage user access reviews, project documents as per GSP/ CSV requirements. + Work effectively with other quality /manufacturing stakeholders. ... Team. + Ensure adherence to cGMP, GSP 111, and CSV 6 requirements across all operations. + Develop, implement,...meet the defined timelines without extensions. + Manage IT quality topics such as change management process. + Manage/lead… more
- US Tech Solutions (San Bruno, CA)
- …for a person based on a comprehensive view of the evidence. **Responsibilities:** ** Quality Assurance Champion:** 1. Act as a champion of Quality Assurance ... and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from… more
- Bristol Myers Squibb (San Diego, CA)
- …orchestration:** Oversee ingestion from diverse sources (vendor feeds, raw instruments, CSV , PDF, etc.), ensuring automated ETL and sample-to-target mapping & ... transformation (STTM) outputs meet stakeholder needs. + ** Quality and profiling:** Assess and validate source data, documenting any cleaning, normalization of… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …skills. Preferred: * Master's degree or quality certifications (eg, ASQ Certified Quality Engineer ). * Experience with Veeva Quality Suite or similar ... Description** Gilead Sciences is seeking a Head of Digital Quality dynamic, experienced, and visionary leader to serve as...Gilead inspections with a focus on GxP digital Compliance ( CSV , Data Integrity etc.) * Oversee validation lifecycle for… more
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