- Randstad US (Research Triangle Park, NC)
- gxp systems lead . + research triangle park , north carolina + posted may 8, 2024 **job details** summary + $65 - $71 per hour + contract + bachelor degree + ... pharmaceutical industry leader to work in our Engineering and Operations team as a contract GxP Systems Lead . This role will report to the Head of IT and … more
- University of Washington (Seattle, WA)
- …of Laboratory Medicine and Pathology has an outstanding opportunity for a **Computer Systems GxP Validation Specialist** **WORK SCHEDULE** + 40 hours per week ... stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment. + Lead and oversee... and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises… more
- Amgen (Thousand Oaks, CA)
- …the range of 5 to 15 individuals. + Design and integrate the Quality Management Systems into a modern GxP Quality Management Operating System across each of the ... a career you can be proud of. **Senior Director, GxP Quality** **Live** **What you will do** Let's do...this vital role as the Senior Director, you will lead the development and execution of a Global, Enterprise-wide… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …issues. **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with ... Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non- GxP activities, assuring that these … more
- BAE Systems (Richmond Heights, MO)
- …self-starter for a position as a Customer Technical Solutions (CTS) Manager for GXP products. Lead employees on providing solutions to current and pending ... customers of GXP products and services. Provide leadership and guidance to...equivalent experience + Minimum of 5 years working in software/ systems engineering, or technical support, specifically in the geospatial… more
- The Estee Lauder Companies (Blaine, MN)
- …and operating systems to eliminate risk of downtime on PC's when patching systems that have locally installed GxP Applications as well as web accessed ... ** Lead , Data Integrity IT Site Technician** **Brand:** Estee...global team to deploy the backup process for all GxP in-scope systems and non- GxP ...the backup process for all GxP in-scope systems and non- GxP and play a key… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Business Process Owners, Facilities, Validation, and Engineering teams to ensure that GxP systems are deployed according to company standards and relevant ... work instructions, and other governing documents to support Gilead's GxP systems . + Provide oversight and QA...and actions. + Demonstrate ability to problem solve and lead process improvements. + Demonstrate ability to lead… more
- CSL Behring (King Of Prussia, PA)
- …audit trail review completion by the business and ensures audit trail availability for GxP systems . + Ensure and monitor compliance with CSV standards of the ... GxP risk assessment, standards, and documents for all GxP systems , and non- GxP relevant...subject matter expertise, as directed by the DQ R&D Systems Lead , to support several training programs… more
- Rhythm Pharmaceuticals (Boston, MA)
- …European Guidelines as related to the Pharmaceutical Industry + Direct experience managing GxP systems (LMS, Veeva Vault) + Experience in Audits, Risk Mitigation ... Rhythm's validated electronic system that houses all of Rhythm's GxP records. The Associate Director QA will lead...a compliant roll out and post-deployment maintenance of critical GxP IT systems + Assist preparations for… more
- Kelly Services (Skillman, NJ)
- …off, including holiday, vacation, and sick/personal time. **Job Opportunity: Global Quality Systems Technical Training Lead ** Are you passionate about ensuring ... impactful initiatives? We are seeking a skilled Technical Training Lead to join our Global Quality Systems ...support. + Oversee project management and execution of the GxP Learning Management System (LMS) across all global sites… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Associate Director, GFE Compliance Enablement Ridgefield will lead all GFE activities related to compliance culture, qualification/validation, ... and GxP compliance enablement. The incumbent will design ...improvement with respect to site operations. This role will lead compliance enablement/validation team. The Associate Director, GFE Compliance… more
- Lilly (Indianapolis, IN)
- …the world. **Position Description** The Sr Principal Associate - QA, QMS Deviation Lead - Parenteral Network represents their network for the One Lilly QMS ... supplier quality management, auditing) across the Lilly enterprise. The Parenteral Network lead supports design and deployment of our core quality management system… more
- United Therapeutics (Durham, NC)
- …continuing education based on findings from oversight activities + Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits ... clinical team in preparing for external audits + Facilitate GXP Compliance/QA audit activities for clinical development to include...Degree (scientific related field preferred) + For Clinical Oversight Lead II level: + 8+ years of experience in… more
- Bristol Myers Squibb (Trenton, NJ)
- …BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic ... report to the Head of GMP Quality and oversee GMP quality systems at RayzeBio Indianapolis. **Job Responsibilities** Essential duties and responsibilities include… more
- The Estee Lauder Companies (Blaine, MN)
- ** Lead , Technology Services Delivery** **Brand:** Estee Lauder Companies **Description** The Estee Lauder Companies (ELC) Inc. is a Fortune 500, multinational ... through both digital commerce and retail channels. The Technology Lead group is an organization within IT with a...onsite DI Tech ensuring support for the Data Integrity ( GxP compliance) while working closely with R&D IT and… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Purified Water System and Clean Lab Gas Systems Lead will supervise day to day operations involved in repair, maintenance, service, ... troubleshooting, operation and monitoring of the purified water systems on site, in order to maintain a continuous...Calibration and Automation to plan / implement changes and lead problem solving activities. You will also collaborate with… more
- Lilly (Indianapolis, IN)
- …settings (eg, Regulatory Affairs, Medical, GCP, GLP, GMP). . Robust knowledge of GxP and Quality Management Systems . . Expertise in program management. . ... role is to establish and maintain the global quality systems which safeguard patient trust. As a member of...of relevance to promote Lilly personnel continuing education on GxP requirements. . **Act as subject matter expert for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the care of patients with life-threatening diseases. Reporting to the Global Quality Systems and Compliance organization, the Quality Systems Specialist III - ... procedures and processes to facilitate the management of physical records in a GxP environment. In this role, you will partner in the development of classification… more
- ThermoFisher Scientific (Greenville, NC)
- …business leadership to drive efficient technology solutions. **What will you do?** + Lead the IT Site Service Function for Pharma Services. The primary services ... Major Incident Management events, Quality, Regulatory, or Sarbanes-Oxley (SOX) audits. GxP regulatory support and customer-specific data delivery. + Provide direct… more
- Sanofi Group (Bridgewater, NJ)
- …qualification is desirable with 10 years' experience in PV databases and other GxP systems **Pursue Progress, Discover Extraordinary** Better is out there. ... PV data strategy and data governance. + Responsible to lead the PV data integration effects with other science...of the safety/pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation. +… more