- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- Abbott (Alameda, CA)
- …Asia, navigating complex regional regulations. + Compliance and Oversight: Ensure compliance with global regulatory standards (eg, FDA , EMA, ISO 13485, EU ... will lead the implementation of a best-in-class digital Quality Assurance and Compliance system optimized for Software as Medical Device. In addition, this… more
- Cedars-Sinai (Los Angeles, CA)
- …needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and ... implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report… more
- Merck (San Diego, CA)
- …with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary ... submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently with regulatory agencies (… more
- Element Materials Technology (Santa Fe Springs, CA)
- …QA operations within a GMP-regulated pharmaceutical environment, ensuring full compliance with applicable regulations, client requirements, and internal quality ... role in maintaining audit readiness, reinforcing a culture of compliance , and ensuring that the laboratory's output meets the...role requires a deep understanding of GMP, ISO 17025, FDA , and ICH requirements, as well as the ability… more
- CSL Plasma (Fairfield, CA)
- …facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies. ... Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all...include, but not limited to: ADA, Civil Rights, EEOC, FDA , GHA, HIPAA, and OSHA. + Maintain confidentiality of… more
- Danaher Corporation (Sunnyvale, CA)
- … compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration ( FDA ), ISO 13485, European Union ... position will work with the Senior Manager Quality Systems Compliance . This position is part of the Quality department.... + Participate in external audit management ( eg FDA , ISO, Danaher Corporate, foreign governments), in either a… more
- Cedars-Sinai (Los Angeles, CA)
- …needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and ... implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report… more
- Abbott (Sylmar, CA)
- …non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in ... and validation, Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure compliance for the same. + Work with R&D and Manufacturing Engineering in the… more
- Sumitomo Pharma (Sacramento, CA)
- …goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and ... protocols. + Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards. + Develop and execute corporate clinical strategy… more