- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... leadership, organizational and administrative skills. + Prior experience with Regulatory Agency interactions. + Pharmaceutical product development experience,… more
- Envista Holdings Corporation (Pomona, CA)
- …develop, implement, and maintain quality assurance protocols that comply with regulatory requirements and industry standards. The Sr. Quality Engineer will possess ... a deep understanding of quality management systems, regulatory requirements, and risk management principles. The Sr. Quality Engineer will report directly to the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … Product Development System + Ensure R&D activities satisfy regulatory standards including documentation and reporting requirements. + Effectively collaborate and ... externally at conferences and scientific meetings. + Represent BDB externally with regulatory agencies, notified bodies, FDA , etc. + Ensure customer perspectives… more
- Element Materials Technology (Santa Fe Springs, CA)
- …Acting as a key link between the laboratory teams and the Quality Manager , this role ensures that all testing activities are executed with accuracy, efficiency, ... of Specifications, and CAPAs, and preparation for client and regulatory audits. The **Quality Supervisor n** ot only ensures...role requires a deep understanding of GMP, ISO 17025, FDA , and ICH requirements, as well as the ability… more
- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... Science, Clinical Development, or Clinical Research is preferred. + Pharmaceutical product development experience + Experienced in global regulatory requirements… more
- Cordis (Irvine, CA)
- …and guiding the operations team through production scale up, end-to-end product realization and associated quality deliverables. The primary focus will be ... at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: Lead the… more
- Abbott (Milpitas, CA)
- …for a wide range of analytical methodologies, approaches and techniques for product characterization. Manage direct reports at manager , and administrative ... of entire medical device development process from needs definition through regulatory approvals, production, launch, and product life cycle maintenance.… more
- Amgen (Thousand Oaks, CA)
- …this! Let's change the world! The Senior Engineer will join Amgen's Drug Product Process Engineering team in the Drug Product Technologies organization. Working ... with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role will be responsible for commercial process… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …a robust Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining ... a robust Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining… more
- Abbott (Alameda, CA)
- …our Alameda, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are ... developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have… more