- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... the interface between the business and the technology providers to deliver GxP application solutions. Responsible for Strategic Application product roadmaps to meet… more
- AbbVie (North Chicago, IL)
- …affairs corporate and/or organizational policies/procedures. Partners with the Director , R&D Quality Assurance on cross- GxP standards and those requiring ... and/or exceed expectations. Serves as thought leader/expert in R&D Quality Assurance strategic insert GxP ... Director of Safety, Vigilance and Medical Affairs Quality Assurance . There is an expectation that… more
- OnKure, Inc. (Boulder, CO)
- Position Description: This position in Quality Assurance provides strategic and technical support of the Quality Management System (QMS) and is responsible ... compliance with regulatory, clinical, and business operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Director of IT, Quality Assurance ...the approach and provide oversight for the Corp. IT GxP Training efforts. Ensure compliance with all GxP ... Research and Clinical Studies QA teams to ensure seamless integration of IT quality assurance practices. Oversee the preparation and management of our Health… more
- Astellas Pharma (Sanford, NC)
- ** Quality Assurance , Site Leader (Senior Director )** Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene ... to join us and be a part of our journey. Astellas is announcing a ** Quality Assurance Site Leader (Senior Director )** opportunity at their **Astellas Gene… more
- Bristol Myers Squibb (Princeton, NJ)
- …(eg, GxP , ISO). + Coordinate with cross-functional teams, including Quality Assurance , Technology Owners, Manufacturing, and IT, to ensure successful ... more: careers.bms.com/working-with-us . **Position Summary:** Lead and manage Computer System Assurance (CSA) efforts for systems and applications in core GxP… more
- Fujifilm (Holly Springs, NC)
- …Practices (GMP) environment. * A minimum of 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility * Experience from ... **Position Overview** The Director , Quality Systems and Support oversees...Learning management, Documentation management as well as deviation and GxP change management system. * Leads the Quality… more
- Teva Pharmaceuticals (North Wales, PA)
- …industries in GxP environment preferred + Functional knowledge on Pharmaceutical Quality Assurance , US FDA and Regulatory Compliance + Demonstrate strong ... Director Commercial Quality US Date: Feb...elements within the US Commercial units by including other GxP supporting functions such as Supply Chain, Regulatory Affairs,… more
- Bristol Myers Squibb (Summit, NJ)
- …to Health Authorities and RGO . + Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit strategies and ... strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use + Translate QMS elements… more
- Bristol Myers Squibb (Devens, MA)
- …Councils across nonclinical, clinical and pharmacovigilance ( final accountability resides with GxP Quality Council Co-Chairs ) ensuring rigor in meeting, ... to derive meaningful , actionable insights that support data-driven decision-making at Global GxP Quality Councils . + Ensure that the right conversations occur… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Working in QA at Gilead:** Quality Assurance delivers on Gilead's commitment to bring life-changing ... **Job Summary:** Gilead Sciences is currently seeking a Senior Director level position to be the leader of Packaging... level position to be the leader of Packaging Quality Assurance Team in the Pharmaceutical Development… more
- Fujifilm (Thousand Oaks, CA)
- **Position Overview** **The Associate Director of QC Microbiology will provide strategic, technical, and operational leadership for QC Microbiology related ... individual will proactively identify and implement industry standard methodologies for Quality Control Microbiology Laboratories. Such efforts are related to rapid… more
- AbbVie (North Chicago, IL)
- …or Engineering) + Minimum 12 years of experience with increasing responsibility in GxP Quality and/or Compliance environment. + Demonstrated capability to work ... Experience in two or more of the following areas preferred: Quality Assurance , Compliance, Regulatory, Clinical Operations, Pharmacovigilance, Manufacturing,… more
- Amgen (Thousand Oaks, CA)
- …opportunities for cost optimization while maintaining the integrity of operations. + ** Quality Assurance & Continuous Improvement:** Implement and maintain a ... transform the lives of patients while transforming your career. R&D Lab Operations- Global Director **What you will do** Let's do this. Let's change the world. In… more
- Bristol Myers Squibb (Summit, NJ)
- …for master data changes + Collaborate within the department and with manufacturing, quality control, quality assurance , IT, global master data management, ... at BMS with our Cell Therapy team. The **Associate Director , Site Supply Chain Systems** , is responsible for...related customer support to manufacturing, site planning, inventory control, quality assurance , quality control, global… more
- Takeda Pharmaceuticals (Columbus, OH)
- …preparation, facilitating requests, managing responses and CAPA strategies. + Partner with Quality Assurance to ensure appropriate audit scopes and clinical ... empower you to shine? Join us as an Associate Director , GCP Excellence in Clinical Trials based remotely reporting...preparedness for audits and inspections. + Partner with R&D Quality to serve the Clinical Sub-Team (CST)/Study Execution Team… more
- Bristol Myers Squibb (San Diego, CA)
- …to be the global leader in radiopharmaceuticals . **Summary** The Associate Director , Facility Contract Management position will act as the site-level single point ... RayzeBio facilities operations, site customers, local and regional Finance, EHS, Quality , Procurement, Human Resources, Global Facilities Services and Global Energy… more
- Takeda Pharmaceuticals (Boston, MA)
- …stakeholders, including Clinical Operations, Pharm Sci, GMS, Clinical Supplies operations and Quality Assurance for batch release planning. + Responsible for ... and empower you to shine? Join us as the Director , Global Clinical Supply Chain Planning based in Cambridge...with Medical Devices a plus. + Advanced knowledge of GxP . Ability to execute exception and change management activities.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... the interface between the business and the technology providers to deliver GxP application solutions. Responsible for Strategic Application product roadmaps to meet… more
- Colorado State University (Fort Collins, CO)
- …met during cGMP biomanufacturing. Individuals will be working within an FDA compatible Quality System using Quality Assurance approved SOPs, protocols and/or ... cGMP regulations and biomanufacturing production scalability. Position Summary The Quality Control (QC) Associates are responsible for the implementation and… more
