- Gilead Sciences, Inc. (Foster City, CA)
- …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 ... oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. + Provide… 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 ... oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. + Support… more
- Cedars-Sinai (Beverly Hills, CA)
- …of study assignments within the group. + Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements. ... progress of screening, enrollment, and data submission. Responsible for ensuring protocol compliance and training of staff supporting the program. + Plans and… more
- Cardinal Health (Sacramento, CA)
- …hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory/ compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong ... + Handle fast paced and high-volume workload + Identify legal and compliance issues and business risks and escalate appropriately + Effectively communicate with… more
- Kelly Services (Pleasanton, CA)
- …including preparing and managing site-specific documentation. + Establish and ensure compliance with GLP, GCLP, and applicable FDA regulatory standards. ... the development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice… more
- Amgen (Thousand Oaks, CA)
- …biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards. The role requires a visionary leader ... models, policies, and risk mitigation strategies to ensure quality and compliance . + Make final decisions regarding standard operating procedures (SOPs), CDM… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting ... non- compliance and mitigating risks, The performance of the Quality...Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment +… more
- Parker Hannifin Corporation (Irvine, CA)
- …responsible for the movement of merchandise in/out of the country in compliance with all federal, Customs and local regulations. QUALIFICATIONS, EDUCATION AND ... to drive on-time delivery goals. + Knowledge of other government agencies (eg, FDA , EAR, ITAR, and OFAC). + Experience in Record keeping requirements, rules, and… more
- Insight Global (San Diego, CA)
- …teams to ensure the highest standards of quality and regulatory compliance for post market hemostasis products. Key Responsibilities: Reviewing Engineering Change ... and approve changes to engineering designs and processes, ensuring compliance with medical device regulations. Attending Standup Operation Meetings: Participate… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …role ensures that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for ... that all IPD products are designed and manufactured in compliance with applicable industry and regulatory standards and meet...staff. * Deep knowledge of global medical device regulations ( FDA , EU MDR, etc.). * ASQ certification (Engineer or… more