- Oura (San Francisco, CA)
- …York) occasionally gather informally at local co-working locations. The AGC, Senior Director of Regulatory Compliance & Privacy will provide strategic legal guidance ... development, clinical validation, and market positioning. + Oversee compliance with Quality System Regulation (QSR) and Good Manufacturing Practices (GMPs), as well… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This ... process monitoring, troubleshooting, and lifecycle management activities conducted by external partners. **Key Responsibilities:** + Lead the upstream development,… more
- IQVIA (Carlsbad, CA)
- …(CRAs), Clinical Research Specialist (CRSs), Clinical Operations' Managers and/or Associate Managers. RESPONSIBILITIES . Manage staff in accordance with ... May participate in country/region coordinated resourcing process. . Manage the quality of assigned staff's clinical work through regular review and evaluation… more
- BeOne Medicines (Emeryville, CA)
- …role, the Medical Writer will serve as a key partner in shaping the external scientific narrative, as well as ensuring data are communicated with clarity, accuracy, ... and impact through high- quality publications and congress materials. This is an individual...oncology + Extensive experience collaborating with cross-functional teams and external experts in a biotech or pharmaceutical setting +… more
- GRAIL (Menlo Park, CA)
- …collaborate with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and ... and the development of submissions in partnership with key internal and external stakeholders for GRAIL projects, including Multi-Cancer Early Detection (MCED). The… more
- Bristol Myers Squibb (San Diego, CA)
- …project teams with key interfaces in IT, bioinformatics, data sci, stats, external collaborators, contractors, other disease strategy leads and asset leads + ... including regulatory, clinical and commercial and scientific communications and external collaborators to develop translational analysis plans and timelines,… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …The position requires establishing and executing a vision that prioritizes safety, quality , and continuous improvement. You will report into the Head of Engineering. ... (WOs) and justify the need for additional resources or external support when necessary + Implement reliability centered maintenance...OpU goal + Optimize the use of internal and external resources to achieve business objectives + Manage the… more
- United Therapeutics (Sacramento, CA)
- …kidneys ( **mirokidney(R)** ), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** ... regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study...regulatory experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area of study… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. **Job Description** We are seeking a Director for a Facilities & Equipment Quality Oversight Support role. The role ... + Experience building effective working relationships across all internal and external stakeholders impacting facilities and equipment quality . + Demonstrate… more
- AbbVie (Irvine, CA)
- …clear resolutions. + Prepare reports to support earnings calls and external communications. + Leads initiatives for new solutions and/or governance improvements ... multiple tasks concurrently in a dynamic environment and ensure production of high quality and timely work product. + Ability to gain alignment and partner… more