- Gilead Sciences, Inc. (Foster City, CA)
- … Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and ... + Well versed in FDA and ICH guidelines relating to registration, quality , and compliance concerning drug substance and drug product. + Proven track record in… more
- Abbott (Santa Clara, CA)
- …and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality , preclinical ... Create, update and maintain EU technical documents. + Assist in compliance with product post-marketing approval requirements. + Assess external communications… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …makes us be outstanding.** Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence ... activities related to Grifols' investigational and marketed products. Ensure high- quality pharmacovigilance deliverables that comply with global regulatory reporting… more
- Kelly Services (Irvine, CA)
- …seeking a Technical Writer 1 for a long-term engagement with one of our Global Pharmaceutical clients. This position is onsite 2-3 days per week in Irvine, CA. This ... change requests and ECO's to ensure complete traceability in a compliance environment. Duties And Responsibilities: + Writes and/or edits technical materials… more
- Philips (Ontario, CA)
- …CA - an air-conditioned FDA regulated manufacturing environment for Medical Devices and Pharmaceutical drugs (ISO 13485). **Your role:** + Effectively work in a high ... weekly and monthly safety meetings, tracking training to ensure compliance with Corporate Regulatory Task Schedule, identifying gaps in...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- J&J Family of Companies (South San Francisco, CA)
- …Head of IMSC Planning and Value Chain Management and Deliver, Head of CMC, and Quality to deliver the portfolio. The leader will represent is the single point of ... DPDS and with the Therapeutic Areas, GDO, IMSC & Quality to ensure alignment of process and systems, sharing...critical activities. + Contributing to building a culture of compliance with safety procedures, healthcare compliance , company… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …in partnership with the EDs of Customer Engagement, US Medical Affairs, US Quality , and Global Analytics & Commercial Operations (GACO) and oversees the team that ... in partnership with the EDs of Customer Engagement, US Medical Affairs, US Quality , and GACO _Provider_ _Access_ _Market_ _ing_ + Oversee development of all… more
- ICON Clinical Research (Los Angeles, CA)
- …including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation ... + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and...or destruction + Resolve data queries and drive timely, high- quality data entry + Document site progress and escalate… more
- Mentor Technical Group (Redwood City, CA)
- …and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical , biotechnology, and medical device safety and efficacy ... operations activities. + Is responsible for overseeing work order activity compliance with respective regulatory requirements (ie FDA, DEA, OSHA). + Manage… more
- Pfizer (Sacramento, CA)
- …we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.Our science and risk-based ... compliant quality culture is innovative and customer oriented. Whether you...oriented. Whether you are involved in manufacturing, testing, or compliance , your contribution will directly impact patients. **What You… more