- Amgen (Thousand Oaks, CA)
- …pre-clinical toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- Philips (San Diego, CA)
- …tools, and innovative methodologies to continuously enhance software quality and regulatory compliance. + Will oversee the development, maintenance, and management ... they are accurate, up-to-date, and fully compliant with relevant standards, regulatory requirements, and internal policies throughout the software lifecycle. +… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working knowledge of FDA safety regulations, ICH ... and Preventative action (CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …leveraging engineering standards, Quality by Design principles, and experience aligned with FDA , ICH, & ISPE guidelines. + Ensure all activities comply with current ... Good Manufacturing Practices (cGMPs), company policies, and regulatory requirements. + Sponsor and oversee process improvements and harmonization projects across the… more
- Cardinal Health (Sacramento, CA)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- Abbott (Sylmar, CA)
- …our life-changing medical device software. You'll work closely with developers, QA, and regulatory teams to ensure our systems are fast, reliable, and compliant with ... FDA and ISO standards. **What You'll Work On** As...pipelines that support traceability, automated testing, and documentation for regulatory compliance. + Help design, implement, and deploy cloud-based… more
- Element Materials Technology (Concord, CA)
- …services that adhere to the quality management system, client requirements, and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP, GMP, FDA , ... to the Validation and Calibration Services (VCS) department, ensuring applicable regulatory standards are adhered to. + Prepares company quality systems review… more
- BeOne Medicines (Emeryville, CA)
- …implementing, and maintaining QMS processes in alignment with organizational goals, regulatory requirements, and industry standards. The Director, QMS Process Owner ... and maintain the Global Change Control process to ensure compliance with regulatory , customer, and organizational requirements. + Act as the primary point of… more
- Cordis (Irvine, CA)
- …for risk mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up to date with regulatory requirements, standards, and ... practices. + Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities + Liaison and ... including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training… more