- Gilead Sciences, Inc. (Oceanside, CA)
- …and help create more tomorrows. **Job Description** We are seeking a Director for a GxP Auditing role. The Director of GxP Auditing will lead Kite's global audit ... program, overseeing the strategic planning, execution, and continuous improvement of GxP audits across the organization. This role includes managing a team of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance . Influence cross-functional SOP content and review/approve as ... drugs and other co-meds for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated ... reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business needs and regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …transparency. This is a quality assurance role, helping maintain global compliance , reinforcing audit excellence, and ensuring the consistent delivery of ... stretched while supported and developed by our diverse and expert team. We are a committed team of highly...completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit… more
- Kelly Services (South San Francisco, CA)
- …CMC quality oversight and late-stage development processes. + Advanced knowledge in GxP Quality principles and regulatory compliance . + Strong communication and ... to the Executive Director of Quality Assurance, you'll collaborate with various GxP functions and will be instrumental in crafting and evolving their quality… more
- BeOne Medicines (Emeryville, CA)
- …internal stakeholders/customers to ensure strategy and delivery are consistent. + Ensure compliance with internal SOPs, GxP standards, and audit requirements. + ... as CMC, Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance . This position will also play a key role in… more
- Ascendis Pharma (Palo Alto, CA)
- …issues/concerns and provide consultation when needed. + Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and ... and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and… more
- Terumo Neuro (Aliso Viejo, CA)
- …medical device industry to contribute to overall quality and regulatory compliance objectives. Encompass a broad spectrum of responsibilities including conducting ... reporting, root cause analysis investigation, and closure. Provide comprehensive compliance direction to clinical study teams and cross-functional partners; ensuring… more
- Kelly Services (Sacramento, CA)
- …to the manufacturing of pharmaceutical products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory ... within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance . + Assist in the development or assignment of training to key… more
- BeOne Medicines (San Mateo, CA)
- …as investigational sites. The role is accountable for maintaining training compliance across the clinical operations organization. This includes ensuring that ... + Serve as the business owner and subject matter expert for SumTotal LMS (or equivalent) within GCO. +...Systems, and vendors to resolve issues or support upgrades. ** Compliance -Driven Curriculum Management** + Manage the complete lifecycle of… more