- 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
- PCI Pharma Services (San Diego, CA)
- …network to pioneer and shape the future of PCI. **Summary of Objective:** The Director of Quality is tasked with defining and promoting a quality mindset across the ... improvement, error reduction, regulatory compliance, and sound fiscal responsibility. The Director of Quality leads the development of site Quality Objectives, site… more
- Terumo Neuro (Aliso Viejo, CA)
- **13125BR** **Title:** Associate Director , Clinical Research (US Remote) **Job Description:** Lead the strategic planning and operational execution of clinical ... including selection, initiation, monitoring, and close-out with strong regulatory and GCP compliance. + Collaborate with Medical Affairs, Clinical Quality Assurance,… more
- Actalent (South San Francisco, CA)
- Job Title: Director of Clinical Development We are seeking a highly skilled Director of Clinical Development with a focus on early oncology development. This ... + Support Health Authority interactions and provide responses to inspection observations and audits . + Assist in the design, execution, and reporting of Phase 2 or… 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)
- …Join Gilead and help create possible, together. **Job Description** **Sr Director : Foster City Manufacturing IT & Operational Technology, Digital Leader** Gilead ... Manufacturing IT/OT and Digital during Quality Investigations, Health Authority Inspections, Audits , and in Regulatory Dossiers. **Team Leadership** + Understand and… more
- Parexel (Sacramento, CA)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... in compliance with Client Procedural Documents, international guidelines such as ICH- GCP , and relevant local regulations and that the sites deliver according… more
- Parexel (Sacramento, CA)
- …close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and ... that site staff have completed and documented the required training appropriately, including ICH- GCP training, prior to and for the duration of the study. Ensures… more
- Cedars-Sinai (Beverly Hills, CA)
- …Research Operations is accountable to the Department Chair and/or Institute Executive Director and serves as the primary source of information for the department. ... for the department and organization. Strategizes and collaborates with the Director and senior leadership, along with Academic Affairs regarding development and… more
- Legence (San Jose, CA)
- …are seeking a highly skilled IT Audit Specialist to lead IT General Controls (ITGC) audits in support of SOC 2 and SOX compliance. This role is critical to ensuring ... processes. The ideal candidate will bring deep experience in ITGC audits , tool selection, continuous improvement, and cross-functional project management. **Key… more