- Cedars-Sinai (Santa Monica, CA)
- …subjects, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and Sponsor representatives to successfully implement research ... protocols, in compliance with all regulatory requirements. **Primary Duties and Responsibilities:**...and federal guidelines. + Acts as a liaison with pharmaceutical company representatives or other project funding organizations to… more
- LGC Group (Petaluma, CA)
- …internal auditing, and supplier management. + Extensive knowledge of ICH, FDA /EMA regulations for Active Pharmaceutical Ingredients and/or Finished ... and Berlin, Germany. Job Description Roles and Responsibilities + Quality & Compliance : Complete all activities adhering strictly to quality and regulatory standards… more
- Sumitomo Pharma (Sacramento, CA)
- Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma ... Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional… more
- Abbott (Menlo Park, CA)
- …teams. + Ensure compliance to product specific standards, cGMP, QSR, US FDA , ISO, IEC, UL, EN, and MDD/MDR requirements and solid understanding of the ... 5 years' experience of Risk Management in the Medical Device or Pharmaceutical Industry, preferably focused on complaint management and Health Hazard Assessments for… more
- Charles River Laboratories (Hollister, CA)
- …customer training, and product validations. * Responsible for completing all service and compliance documentation as required by company policy, cGMP and FDA . * ... our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic… more
- Fortive Corporation (Irvine, CA)
- …facility systems, and capital projects with a focus on quality, compliance , and operational excellence. **Key Responsibilities:** Design and develop mechanical ... productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** Bachelor's… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... and support interactions with health agencies. + Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain,… more
- United Therapeutics (Sacramento, CA)
- …are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- Mentor Technical Group (Millbrae, CA)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... portfolio of technical support and solutions tailored to the FDA -regulated industry. As a world leader in life science...System (CMMS). + Ensure all work is performed in compliance with GMP, OSHA, Cal/OSHA, and environmental regulations. +… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. ... officials. Ability to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company objectives. Ability to… more