- Nestle (Bridgewater, NJ)
- …and communication. + Act as a subject matter expert for the IT GxP Compliance Program. + Partner with QA to manage systems validation, periodic ... + Support Clinical Operations, Biometrics, and data management systems to ensure IT GxP compliance . GxP System Operations: + Oversee application… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** + The Engineer - IT Compliance , Cell Therapy at Devens Cell Therapy Facility (CTF) ... Life Cycle standards. This role will primarily support the IT Compliance , IT Deviation Management,...Devens CTF. + Acts as a CSV Subject Matter Expert (SME) for computerized system related changes and associated… more
- Cambridge Isotope Laboratories, Inc. (Xenia, OH)
- …technologies. + Experience with Microsoft Dynamics 365 F&O. + Familiarity with FDA GxP compliance is strongly preferred. Benefits CIL and CIS offer a ... Cambridge Isotope Separation (CIS) has an outstanding opportunity for an IT Systems Engineer based in our Xenia, Ohio location. CIS is the world leader in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and improve life by advancing the care of patients with life-threatening diseases. **Senior IT Business Systems Analyst (Legal)** Gilead IT is looking for a ... domain with a primary focus supporting the Legal organization's IT applications. The person selected for this role will...It is expected that this person with become the expert in their assigned business functions, including their business… more
- BeiGene (San Mateo, CA)
- …needs and the Quality Strategy. + Act as the system owner for all digital GxP enterprise Quality applications. + Maintain the Digital QMS in compliance with ... implementations and enhancement projects in collaboration with Business Process Owners and IT . + Define and maintain a digital quality systems onboarding and… more
- Kelly Services (Boston, MA)
- …of clinical trials in the cardiac gene therapy programs. * Provide expert clinical operations leadership, ensuring that clinical trial designs are scientifically ... clinical trial teams, ensuring that all aspects of trial conduct are compliant with GxP , ICH, and FDA/EMA regulations. * Act as the clinical lead in interactions… more
- Kelly Services (Boston, MA)
- …of clinical trials in the cardiac gene therapy programs. + Provide expert clinical operations leadership, ensuring that clinical trial designs are scientifically ... clinical trial teams, ensuring that all aspects of trial conduct are compliant with GxP , ICH, and FDA/EMA regulations. + Act as the clinical lead in interactions… more
- Pfizer (Collegeville, PA)
- …digital solutions from concept design, prototyping, to development and release. Work with R&D IT teams to identify and manage data security risks and GxP ... discipline and 10+ years clinical development and operations experience, including expert knowledge in clinical trial conduct, clinical, monitoring and regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …can be optimized, especially on validation issues for new technologies. Provide expert input to stakeholders aimed at avoiding non- compliance risks that ... and global organizational structures and processes with broader impact supporting the IT application and template landscape. Takes active advises on setting up… more
- Sanofi Group (Cambridge, MA)
- …Global External Manufacturing function. This position provides quality leadership and compliance oversight for multiple products manufactured by CMOs and Alliance ... manufacturing network while driving continuous improvement and ensuring regulatory compliance . **Main Responsibilities:** + Serve as the primary Quality contact… more