- GRAIL (Menlo Park, CA)
- …Events and CAPAs; and participating in risk management activities. + Conducting GCP audits of internal processes, clinical investigator sites, and clinical ... from inspections, audits , and emerging clinical compliance trends, in both GCP and CDx domains. + Contribute to, implement, and continuously improve quality… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director , Head, ICSR Management ... are processed in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head, Global PV Operations within ... the direction of the Head, Global PV Operations, the Director , ICSR Management Team is responsible for the oversight...in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations + Analyze trends to identify process gaps, ... inspection and CAPA management team within Gilead R&D Quality on internal audits , regulatory agency inspections, risk assessment, deviations and CAPA activities +… more
- Keeper Security, Inc. (El Dorado Hills, CA)
- Keeper Security is hiring an experienced and highly motivated Senior Director of Technical Operations to lead our Security Operations Center (SOC) and Network ... defend against cyber threats at KeeperSecurity.com. About the Job As the Senior Director of Technical Operations, you will develop and execute a unified vision that… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and high-quality clinical data that supports clinical study endpoints. **Associate Director , Biomarker and Bioanalytical Operations** leads a team of direct and/or ... external partners to ensure inspection readiness and support regulatory audits as needed + Serve as a vendor issue...for Human Use (ICH) guidelines and Good Clinical Practice ( GCP ) governing the conduct of clinical studies. + Proven… more
- Danaher Corporation (Brea, CA)
- …be a part of the Clinical Compliance team and report to the Sr. Director of Global Clinical Compliance responsible for clinical quality and scientific writing to ... have the opportunity to: + Plan and execute internal audits of clinical trials, sites, vendors, and systems, and...+ Certified auditor (eg, ASQ CQA or ASQ CBA, GCP ) + The technology and assays related to in… more
- Ascendis Pharma (Palo Alto, CA)
- …all safety reports received from any source are reviewed according to ICH- GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with ... proactive surveillance of products in development. . Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV… more
- Palo Alto Networks (Santa Clara, CA)
- …The Principal Governance, Risk & Compliance (GRC) Engineer will report directly to the Director of GRC. In this pivotal role, you will serve as a senior individual ... technical execution of customer trust initiatives, including supporting customer audits , completing complex security questionnaires, maintaining standardized Information Security… more
- University of Southern California (Los Angeles, CA)
- …managers, and other hospital personnel. The Coordinator is accountable to the Medical Director and Associate Director of CISO and to the Principal ... patients' time on study. 4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially concerning the reporting of… more