- 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
- 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
- BeiGene (San Mateo, CA)
- …degree with 12+ years, Masters with 8+ years, or PhD/PharmD/MD with 6+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global ... **General Description:** The Senior Director , Digital Quality Management Systems (QMS)...+ Act as the system owner for all digital GxP enterprise Quality applications. + Maintain the… more
- Bristol Myers Squibb (Devens, MA)
- …current Good Manufacturing Practices (cGMPs). This position reports to the Associate Director , Quality Assurance Shop Floor. **Key Responsibilities** + ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** As the Senior Manager Days, Quality Assurance Shop Floor (QASF) you play a pivotal role… more
- GE HealthCare (Arlington Heights, IL)
- …1 within Pharmaceutical Diagnostics (PDx). This role will either report to the Senior Director Global Compliance & Quality Systems PDx or the Global Quality ... all departments. + Lead the knowledge increase of Sterility Assurance to non GxP personnel. + Develop...is aligned to the regulations + Support the PDx Quality Risk Management program and deputise where relevant +… 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: Mar...elements within the US Commercial units by including other GxP supporting functions such as Supply Chain, Regulatory Affairs,… more
- Bristol Myers Squibb (New Brunswick, 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …collaboratively and cross-functionally with BAS Management, appropriate stakeholders and the Quality Assurance Unit (QAU) to improve the overall documentation ... Regeneron's Quality Control group, located in Tarrytown NY, is seeking an Associate Director . In this exciting role you will be responsible for the oversight of… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Excel in a quality driven organization + Have prior experience in a Quality Assurance and/or IT organization + Have experience leading the implementation of ... We are currently looking to fill a Associate Director , IT Quality position. This position...organizations supporting information technologies and systems. + Promote a GXP and quality mentality across the organization.… 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
- Fujifilm (Holly Springs, NC)
- …Science, Engineering Science, Process Engineering, Validation, and Automation * Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, ... for you to lead and grow in a world-class Quality organization as the Director , QA Drug...**Preferred Requirements:** * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups. * ... The Associate Director , Global Development Quality Inspection Management...working in either a quality /compliance role (eg, Quality Management, Quality Assurance etc.),… more
- Takeda Pharmaceuticals (Boston, MA)
- …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
- 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
- Fujifilm (College Station, TX)
- …will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation ... daily briefings and update as needed + Assist QC Director and QC Managers + Ability to work cross...Managers + Ability to work cross functionally with other Quality Control groups, Quality Assurance ,… more