- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Lead technical professional experienced in designing, implementing, documenting, and executing complex technical projects. A person in this position is expected to possess an expert level… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and the nature of associated clinical trials across phases. + Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical ... procedures. + Strong communication and organizational skills. + PhD in biostatistics or related discipline with 2+ years' relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry or a related environment. PhD… more
- GRAIL (Menlo Park, CA)
- …management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA -regulated environment, with a strong track record of EDC system ... implementation and collaboration with study teams to ensure data quality. + Bachelor's degree required; advanced degree preferred. Additional coursework in programming, analytics, or related disciplines is strongly desired. + Experience working on IDE trials… more
- Charles River Laboratories (Hollister, CA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- ThermoFisher Scientific (San Francisco, CA)
- …required. **Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality, regulatory and ... production attitude with an appreciation for client service and the contract manufacturing industry. + Requires PC knowledge and abilities using Microsoft Office (Word, Excel, Access, PowerPoint) products. + Requires interpersonal skills and the ability to… more
- CVS Health (San Diego, CA)
- …records in compliance with state and federal regulations. Complies with FDA mandates and self-imposed manufacturer restrictions on particular drugs, as applicable. ... 7. Participates in Performance Improvement activities, educational programs, and departmental/branch meetings. 8. Assists in training and orientation of new employees as requested by pharmacy manager or designee. 9. Performs other duties and responsibilities… more
- Insight Global (San Diego, CA)
- …management experience (working in a pharmaceutical company with exposure to FDA regulations preferred) * Experience managing technical implementation projects in ... support of business applications * Experience with cloud-based softwares/platforms (Veeva, ServiceNow, NetSuite) o Familiarity of Veeva and it's support functions including: clinical, quality, safety& regulatory * Experience with ERP * Experience with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and ... Gilead's quality system requirements. Plan and implement approved quality improvement action items and deliverables. + Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device… more
- Cytel (Sacramento, CA)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- Astrix Technology (Pomona, CA)
- …personal care products comply with industry regulations and standards, such as FDA guidelines, and work towards continuous improvement in meeting these requirements. ... + Collaborate with production and quality teams to identify areas for process improvement and implement corrective actions to prevent defects and non-conformities. + Communicate with the production team to address and resolve quality issues, deviations, or… more