- Kelly Services (Pleasanton, CA)
- …including preparing and managing site-specific documentation. + Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards. ... bioanalytical or pharmaceutical company. + Subject matter expert in GLP compliance , regulations, and requirements. As part of our promise to talent, Kelly… more
- Amgen (Thousand Oaks, CA)
- …**Preferred Qualifications:** + Experience within clinical data management, regulatory compliance , and strategic leadership within a pharmaceutical , biotech, ... regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards. The role requires a...or CRO environment. + Expertise in GCP, ICH, FDA , EMA regulations, data governance, and clinical trial data… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …Quality on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency. Beyond quality oversight, the role contributes to ... to support Quality decisions on the shop floor, ensuring compliance with standards and procedures + Implement and maintain...management role with direct reports + Deep knowledge of FDA , EMA, CFDA, and PDA regulations, including Good Data… more
- Ascendis Pharma (Palo Alto, CA)
- …appropriately + Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements + Ensuring SP/vendor oversight under the guidance of Head ... risk and develop strategy and action plans to ensure compliance + Overseeing and supporting implementation of CAPAs as...Bachelor's degree in a health care field with relevant pharmaceutical industry experience in drug safety. + Candidates with… more
- Charles River Laboratories (Hollister, CA)
- …and protection of the environment for the businesses. + Ensure facility compliance with applicable environment health and safety regulations. + Implement site audit ... program of the EHS&S compliance of the site, track and report status of...our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Compliance & Risk Management: Ensure all legal technology solutions align with global compliance frameworks (eg, GDPR, FDA , EMA) and company policies. + Team ... driving the strategic implementation of legal technology solutions to enhance efficiency, compliance , and cost management within the legal department. As a senior… more
- BioLife Plasma Services (Sacramento, CA)
- …management. Gain exposure to real-world challenges such as audit processes, compliance requirements, and team performance management. + **Production Environment & ... service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee Relations… more
- Element Materials Technology (Concord, CA)
- …customer expectations at Element Concord. The Manager's main duties are to ensure compliance and accuracy when reporting results to clients. The Manager must provide ... requirements, and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP, GMP, FDA , and ICH guidelines. The **Quality Manager** monitors and advises on how… more
- Ascendis Pharma (Palo Alto, CA)
- …(CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and ... submission to Health Authorities or partners as applicable. + Ensure any non- compliance or late ICSR are identified and ensure deviations are filed in accordance… more
- BeOne Medicines (San Mateo, CA)
- …(zanubrutinib), TEVIMBRA(R) (tislelizumab), and future products in our pipeline pending FDA approval. This individual will develop our digital strategy and apply ... to ensure all final resources meet our business objectives while ensuring compliance . + Lead operational tactics such as master service agreements negotiations, SOW… more