- Highmark Health (Sacramento, CA)
- …team of specialists. Identify, develop, coordinate, and implement legislative, regulatory , sub- regulatory , and licensing / accreditation requirements.Perform ... ongoing monitoring and analysis of external regulatory and industry intelligence, collaborating with impacted stakeholders, and providing regular, executive… more
- Novo Nordisk (Bloomington, CA)
- …and enforcing organization standards, adhering to legal regulations o Represent Quality Assurance Program in Customer Joint Steering Committees . All other duties ... or other regulated industry . 5 years providing quality assurance support to cGMP pharmaceutical production or other regulated...able to develop useful strategies and tactics to meet regulatory milestones o Well organized with ability to handle… more
- Cardinal Health (Sacramento, CA)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements ... services are properly reviewed for quality and documented. **_Job Summary_** The Senior Specialist, Quality Assurance executes quality programs, policies, and… more
- SLAC National Accelerator Laboratory (Menlo Park, CA)
- …complex Contractor Assurance Management Program or functions in consultation with senior leadership. Issues and Improvement Program: + Provides guidance to ... Contractor Assurance Management Program Liaison Job ID 6321 Location...the organization and communicates or escalates notable concerns to Senior Management Team (SMT). + Manages any issues tracked… more
- Abbott (Alameda, CA)
- …place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Affairs Specialist** will work on-site out of our ... with our new sensing technology. **The Opportunity** As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... required. + 12+ years' experience in positions of increasing responsibility in Regulatory Compliance and/or clinical (GCP) quality assurance + Experience leading… more
- Actalent (Agoura Hills, CA)
- Job Title: Regulatory Specialist Job Description As a Senior Regulatory Specialist, you will develop and implement medical device regulatory strategies ... and maintain regulatory procedures, work instructions, and training materials. + Provide guidance to junior regulatory team members as needed. + Work with a… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Abbott (Sylmar, CA)
- …Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management + Assist in the development of multicountry ... review process to ensure submission approval + Provide strategic input and technical guidance on regulatory requirements to development teams + Manage and… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for Women! In ... to complete time-sensitive projects. * Prepare, review, and submit and provide regulatory input and guidance to cross-functional partners regulatory … more
- Hologic (San Diego, CA)
- …to meet organizational goals. + Participates in product development core teams as regulatory representative, as assigned. + Provides guidance on regulatory ... knowledge to all internal stakeholders. + Consults with and provides advice to senior management on strategies and plans for regulatory product approvals and… more
- AbbVie (Irvine, CA)
- …solutions, and/or active pharmaceutical ingredients). + Strong quality assurance /control, manufacturing, laboratory, technical support, regulatory , and/or ... corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or… more
- Howmet Aerospace (Carson, CA)
- Howmet Fastening Systems (HFS) is looking for a Senior Quality Manager at our manufacturing plant in Carson, CA. The Quality Assurance Manager develops and leads ... products that meet required Product Standards as described in AS9100 and Quality Assurance Manual. This is a key change agent position accountable for results, with… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory /CMC, EHS, Finance, IT, and Engineering. **Project Team Management:** + Oversee ... Sciences La Verne Engineering is seeking a highly motivated and knowledgeable ** Senior Manager, Project Management New Product Line Manufacturing - Labeling** , to… more
- Southern California Edison (Etiwanda, CA)
- **Join the Clean Energy Revolution** Become a **Transportation Services, Senior Specialist - Crane Operations** at Southern California Edison (SCE) and build a ... keeping the SCE electrical grid healthy and strong. The Senior Specialist receives, processes & coordinates various Crane requests,...Reports to the Manager 1 who provides oversight and guidance of work being performed and provides back up… more
- Abbott (Pleasanton, CA)
- …and make sound design recommendations, in accordance with Company and regulatory requirements/ guidance , and standards. This position provides leadership and ... health and get on with their lives. As a Senior Manager focusing on Software Quality and associated design...contributor, as necessary. **What You'll Work On** + Provide guidance and strategic input to teams for development of… more
- Abbott (Pleasanton, CA)
- …demeanor. **Preferred Qualifications** + Master's degree + experience in Quality Assurance , Regulatory Compliance, or related roles within the medical ... and scientists. **The Opportunity** We are seeking a strategic and experienced ** Senior Manager, Quality Systems** to lead our global internal audit and compliance… more
- Vera Therapeutics (Brisbane, CA)
- …contact with key stakeholders including Drug Product, Analytical sciences, Quality Assurance , Regulatory Affairs, Supply chain, Finance, and Program Management. ... Title: Senior Manager, Process Development, Downstream Location: Brisbane, CA...other key functions such as project management, QA and Regulatory , the ideal candidate must be an outstanding leader… more
- Jacobs (Oakland, CA)
- …transportation, and renewable energy projects. * Develop permitting strategies, provide regulatory guidance , and direct surveys for biological resources to ... environmental compliance efforts. * Support other permitting project managers as a senior technical lead, providing regulatory permitting strategy support and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to ... Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance , Regulatory , and Project Management Office - to develop… more