- BeOne Medicines (Emeryville, CA)
- …role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and ... Audit : Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and compliance with applicable regulations and guidelines that ensure sustained GCP /QSR compliance . + **Vendor Management:** Leads and develops systems for ... procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting… more
- Cisco (San Jose, CA)
- … Compliance Architect, or similar roles with a focus on security and compliance + Expertise in (AWS, Azure, GCP , etc.) Cloud Security, Compliance ... Architect - Technical Lead - Security & Compliance / Cloud Software Apply (https://jobs.cisco.com/jobs/Login?projectId=1448877) + Location:Offsite, San Jose,… more
- Ascendis Pharma (Palo Alto, CA)
- …and supporting implementation of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to ensure ... discuss new MAP-related processes. + Through coordination with Ascendis GCP and PV Compliance team will provide...Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related… more
- Terumo Neuro (Aliso Viejo, CA)
- …and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical report writing, ... Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH...skills, ability to coach and mentor. 4. Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. ... as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and… more
- Ascendis Pharma (Palo Alto, CA)
- …Ascendis Pharmacovigilance System Master File (PSMF) + Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation ... 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)
- …proactive surveillance of products in development. . Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during ... Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local… more
- GovCIO (Sacramento, CA)
- **Overview** GovCIO is currently hiring for a **Google Cloud Associate ( GCP Cloud SME)** to support our customer, USPS and their CIO Architecture, Strategy & ... solution design to the overall architecture for Enterprise applications and compliance with defined technology standards, policies, processes and best industry… more
- Bristol Myers Squibb (San Diego, CA)
- …(input on inclusion/exclusion and other safety-related clinical considerations) + Fulfills GCP and compliance obligations for clinical conduct and maintains ... all required training + Acts as a focal point for defining and establishing relationships with key global Phase I Centers + Works on multiple trials across early development clinical lifecycle **Clinical Development Expertise & Strategy** + Designs and… more