- Vera Therapeutics (Brisbane, CA)
- Title: Job Title: Associate Director , GxP Systems Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Associate Director , GxP Systems will report to the Sr.… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director , Digital Quality Management Systems (QMS) Operations and User Experience, is responsible for ensuring the ... performance, streamlining processes, and delivering comprehensive support and training. The Associate Director works closely with business users, IT teams,… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with the following duties: Oversee the establishment… more
- Bristol Myers Squibb (Seattle, WA)
- …solutions. + Integrate software with laboratory instruments, robotics, and imaging systems to support automated cell therapy processes. + Participate in the ... code reviews, and adherence to regulatory standards (eg, GMP, GxP , FDA, IEC 62304) as applicable. + Troubleshoot, debug,...62304) as applicable. + Troubleshoot, debug, and upgrade existing systems to enhance performance and reliability. + Work in… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to Enable Documentation - Participate in creation and review of new / updated GxP procedures + Advanced skill level with Microsoft Visio + Experience with Signavio - ... and verbal + Prior experience as business analyst or business / systems architect + Experience writing technical documents such as policies, standard operating… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Associate Director (AD), GCOE Learning and Development responsible for managing the governance, configuration, and optimization of ... processes. + Lead system enhancement projects and coordinate with IT, L&D Systems , and vendors to resolve issues or support upgrades. **Compliance-Driven Curriculum… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director , Supply Chain will lead and grow a supply chain team ... Strong supply management experience/knowledge in forecasting, demand/supply planning, IRT systems , inventory management/ERP systems , clinical labeling, distribution… more
- OnKure, Inc. (Boulder, CO)
- …Business system owner for the electronic QMS and support the Quality Systems Associate with: Drafting and periodic review of controlled documentation, ... industry; including experience in development phase GMP QA Strong knowledge of GxP regulations, Quality Systems (including Document Control, Training, Change… more
- Merck (Rahway, NJ)
- …facility in Rahway, New Jersey. The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and ... Ability to prepare Standard Operating Procedures (SOP) and current GXP documents. + Experience with quality systems ....current GXP documents. + Experience with quality systems . + Excellent organizational skills. + Desire and willingness… more
- BeOne Medicines (Emeryville, CA)
- …and user access. + Ensure compliance with internal policies, GxP requirements, industry regulations, and external standards, mitigating risks associated ... for software delivery. + Experience integrating ServiceNow with other enterprise systems (eg, HR, ERP, monitoring tools). **Soft Skills:** + Exceptional… more
- Rhythm Pharmaceuticals (Boston, MA)
- …a state of inspection readiness. The Manager, QA, Global QMS will report to the Associate Director , QA who is based in the Boston office, while supporting and ... Ensure accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments. + Assign and manage GxP training via… more
- BeOne Medicines (Pennington, NJ)
- …judgment. This role will be based in Hopewell NJ and report to the Associate Director Utilities in Facilities and Engineering. **Essential Functions of the ... experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Strong experience with one of the… more
- Fujifilm (College Station, TX)
- …smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **Reports to** Associate Director , Validation **Work Location** College ... Manager, CSV will be responsible for management, scheduling, and oversight of all GxP -Regulated Computerized Systems at all applicable points of the computerized… more
- Cambrex High Point (High Point, NC)
- …submission of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director , Quality Assurance + Author and Revise Quality Documents ... and/or lead project and site risk assessments relative to quality management systems and impact to client projects/regulatory filings. + Obtain, maintain, and manage… more