- BioLife Plasma Services (Sacramento, CA)
- …exceptional customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and ... application is true to the best of my knowledge. **Job Description** ** Manager Trainee - Operations (Travel Program - Relocation Required)** **Position is based… more
- ThermoFisher Scientific (San Francisco, CA)
- …Trend Reports required. **Knowledge,** **Skills** **and Abilities:** + Exceptional cGMP, GLP and FDA compliance knowledge. + Possess a highly developed quality, ... Manufacturing Practices (GMP) Safety Standards, Office **Job Description** **Title: Quality System Manager ** **Schedule:** Standard 1st Shift - Mon to Friday As part… more
- BeOne Medicines (Emeryville, CA)
- …responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and industry standards, in accordance with applicable ... regulatory requirements, guidelines, laws and internally established standards and...with supporting and involvement in GCP inspections (main inspectorates ( FDA , EMA, CFDI etc.,)) and other country specific inspectorates… more
- Gilead Sciences, Inc. (Foster City, CA)
- …comparator drugs and other co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance documents such as CFR, Annex ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
- Merck (Sacramento, CA)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- Abbott (Pleasanton, CA)
- …qualifications. You will manage project timelines, budgets, and deliverables, ensuring compliance with regulatory requirements. **What You'll Work On** + ... their health and get on with their lives. Project Manager for the Supplier Excellence Taskforce aims is to...drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA , ISO 13485). +… more
- Philips (San Diego, CA)
- …tools, and innovative methodologies to continuously enhance software quality and regulatory compliance . + Will oversee the development, maintenance, and ... The Sr. Manager -Software Design Assurance will play a critical role...designs/inputs, overseeing the review of test/performance data to ensure compliance with quality, safety, and regulatory standards,… more
- Sumitomo Pharma (Sacramento, CA)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Medtronic (Northridge, CA)
- …Partner with product, regulatory , security, and device engineering teams to ensure compliance with FDA , ISO, HIPAA, GDPR, and other global standards. + ... managing their disease. Role Overview We are seeking a Senior Software Engineering Manager to lead our Cloud Development team responsible for delivering patient and… more
- Sumitomo Pharma (Sacramento, CA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more