- Gilead Sciences, Inc. (Foster City, CA)
- … strategies and regulatory strategies for drug substance and drug product quality attributes across all PDM ( Pharmaceutical Development & Manufacturing) ... data integrity + Well-versed in FDA and ICH guidelines relating to registration, quality , and compliance concerning drug substance, drug product, and devices +… more
- Dignity Health (Redding, CA)
- …of policies and procedures, supervision and training of staff, inventory management, quality assurance, and regulatory compliance . The Manager of Pharmacy ... and different approaches to existing programs required + Demonstrated quality improvement competencies required + Demonstrated understanding of utilization and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …service providers for additional system configurations, enhancements, and upgrades. + ** Compliance & Quality Assurance:** o Ensure SAP PLM Specification ... data management, working closely with cross-functional teams including R&D, Engineering, Quality , and IT. The Senior Manager will ensure the integrity, governance,… more
- BeOne Medicines (Emeryville, CA)
- …and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and ... of regulatory submissions, eg, IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with… more
- BeOne Medicines (Emeryville, CA)
- …including tasks related to non-compartmental analysis (NCA), data visualization, table generation, quality control (QC) of results, and data curation to support ... + Ensure accuracy and clarity in data presentation. + Quality Control (QC) of Results: + Perform...checks on analysis results to ensure data integrity and compliance with internal and regulatory standards. + Document QC… more
- Curia (Camarillo, CA)
- …organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At ... to assist in identifying workplace safety and health risks and in implementing control measures that align with Curia Corporate initiatives. The EHS Manager is… more
- ThermoFisher Scientific (San Francisco, CA)
- …**Experience** + At least 2 years of team lead experience in a Quality /Analytical role within the pharmaceutical industry. + Knowledge of QC microbiology ... + Perform all functions within the QC Microbiology laboratory ensuring site compliance with regulatory and corporate requirements. + Coordinate work schedules for… more
- Bristol Myers Squibb (San Diego, CA)
- …all aspects of data management, from planning and coordination to execution and quality control . The successful candidate will be responsible for managing ... meets the requirements of the study objective and company quality standards. + Manage and provide oversight of data...Contribute to SOP development and updates to meet regulatory compliance and operational needs. + 10% of travel required.… more
- Edwards Lifesciences (Irvine, CA)
- …and optimal operations in collaboration with key stakeholders (eg Quality , Engineering). * Identifying issues, reviewing capacity requirements and maintenance ... ensuring team members perform check list actions for all equipment in compliance with established work instructions and adherence with SOPs, including recording… more
- e CancerCare (Fresno, CA)
- … quality improvement objectives, and safety, environmental and/or infection control standards Regular attendance and punctuality. Perform any other functions as ... patient information and oversight of information and dispensing systems. Assist with compliance Federal, State and local laws and regulations as well as proper… more