- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... leading a global team focused on R&D Quality . This global role includes direct reports in the...compliance with applicable regulations and guidelines that ensure sustained GCP /QSR compliance. + **Vendor Management:** Leads and develops systems… more
- Bausch + Lomb (Sacramento, CA)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance , Pharmacovigilance/GPSS and Drug/Device Safety, and ... study objectives are being met and provide the operations director and/or senior management with timely updates on progress...GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… more
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with ... for employees to grow and develop their skills. The Director , Head, ICSR Management Team reports to the Head,...in the safety database and are reported according to ICH- GCP guidelines, Healthy Authority regulations and company SOPs, Work… more
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Contribute to the ... employees to grow and develop their skills. The Associate Director , PV Vendor Management Team reports to the ...of PV Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source… more
- BeOne Medicines (Emeryville, CA)
- …Clinical Development or a directly related area. + Minimum of 3+ years in GCP -related discipline/ quality assurance role. + Has impeccable ethics. Exercises ... **General Description:** The Director Global Clinical Compliance builds, collaborates and manages...drug development, preferably in a relevant field such as Quality Assurance , Supply Chain (commercial and/or clinical),… more
- Gilead Sciences, Inc. (CA)
- …to maintain document compliance with ICH- GCP and SOPs + Partner with Quality Assurance /Compliance teams for risk mitigation, CAPAs, and issue resolution + ... Gilead and help create possible, together. **Job Description** The Associate Director , Clinical Records & Information Management is responsible for partnering with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit ... Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within… more
- AireSpring (Irvine, CA)
- …lead cross-functional teams including Project Management, Business Analysis, Software Development, and Quality Assurance . The ideal candidate will bring a strong ... are seeking a dynamic and experienced Senior Manager or Director of Software Development to lead and scale our...and best practices that improve development efficiency and product quality . + Stay current with industry trends and best… more
- BeOne Medicines (San Mateo, CA)
- …Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance .) + Experience training on CTMS, TMF systems, ... **General Description:** The Associate Director (AD), GCOE Learning and Development responsible for...or automation within LMS environments. + Thorough understanding of ICH- GCP regulations. + Demonstrated expertise in instructional design, adult… more
- Pfizer (South San Francisco, CA)
- …Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance . + Experience building consensus and ... of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results… more