- Genentech (Oceanside, CA)
- …plant operations and manufacturing data. The candidate will report to the Site Head of IT/OT, an organization that is currently undergoing a transformation towards ... OT team you will have responsibilities for IT OT compliance and Validation ensure compliance for all...Represent ITOT in internal(SSI, GARA, quality etc.) and external audits( FDA etc.). + "Right to Operate" : Manage ITOT… more
- Ascendis Pharma (Palo Alto, CA)
- …fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in Endocrinology Rare ... skills. The Associate Director, ICSR Management Team reports to the Director, Head , ICSR Management Team within the Global Patient Safety (GPS) organization. Under… more
- Ascendis Pharma (Palo Alto, CA)
- …fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in Endocrinology Rare ... of absence. The ICSR Management Lead reports to the Head , ICSR Management within the Global Patient Safety (GPS)...+ Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Lilly (San Diego, CA)
- …as well as regulatory strategy development + Monitor patient safety and ensure compliance with GCP, FDA , ICH guidelines, and company policies **Cross-Functional ... Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning + Contribute medical expertise to… more
- Kelly Services (South San Francisco, CA)
- …Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse event (AE) reporting, and ... and approach within Medical Safety by assisting the department head . Note this position requires a Doctor of Medicine...be performed remotely from any location within the continental US The position will report to Senior Director, Medical… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …+ Maintain applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards ... and drive procedural improvements. + Support internal and external audits (eg, FDA , Corporate Quality Assessments) by ensuring compliance with procedures,… more
- Parexel (Sacramento, CA)
- …Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), is responsible for the execution of ... trends and provide relevant feedback to the CQOL and Head of CQO as appropriate within a specific therapy...Contact (POC) for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the Clinical Operations… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …to the best of my knowledge. **Job Description** About the role: As the Head of Critical Utilities, you are responsible for ensuring the safe, compliant, and ... prioritizes safety, quality, and continuous improvement. You will report into the Head of Engineering. **How you will contribute:** + Establish priorities that align… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMPs), environmental health and safety ... that behavior as acceptable. Supervisors must promote the appropriate behavior, compliance , cleanliness, and culture of Takeda. **How you will contribute:** +… more
- Nestle (Los Angeles, CA)
- …the globe, and benefits that support physical, financial, and emotional wellbeing. Join us to innovate for impact and reimagine the future of health and nutrition ... for patients and consumers. **Position Summary:** Reporting to the Head of Global Regulatory Affairs Pharma, the Regulatory Affairs Advertising, Promotion, and… more
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