- Vera Therapeutics (Brisbane, CA)
- …compliance, and operational readiness for commercial launch. Working with Quality Assurance , Medical Affairs, Regulatory Affairs, Clinical Operations, ... Title: Job Title: Associate Director , GxP Systems Location: Brisbane, California...responsible for leading the implementation, validation, and support of GxP -regulated systems to enable Quality , Regulatory, Clinical,… 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 Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, ... Studies QA teams to ensure seamless integration of IT quality assurance practices. * Lead all aspects...in compliance and audit-ready. * Ensure compliance with all GxP regulations, including GMP, GCP, and GLP, SOX, and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of quality processes and records, ensuring operational excellence in GxP compliance, and maintaining a state of inspection readiness. The Manager, QA, ... Amsterdam office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution...Global QMS will report to the Associate Director , QA who is based in the Boston office,… more
- BeOne Medicines (San Mateo, CA)
- …or related field required. Advanced degree preferred + Minimum of 8+ years in Quality Assurance in a Pharmaceutical / Medical Device industry in a global ... **General Description:** The Associate Director , Digital Quality Management Systems (QMS)...remain compliant with regulatory requirements (eg, US, EU, ICH GxP ). + Work cross-functionally to implement AI-driven and automated… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …- eg, Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance , Regulatory, and Project Management Office - to ... supply chain best practices and experience working with a GxP environment. The Senior Director , Global Clinical Supply Chain also has strong cross-functional and… more
- BeOne Medicines (Pennington, NJ)
- …minimum 10 years of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control systems, or Master's Degree ... **General Description:** The Senior Director GTS Quality will be the...of relevant work experience in building, configuring, and supporting Quality Assurance and/or Quality Control… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and Skill: 15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance , Validation and Qualifications, Quality System ... QA Director - Site Investigations & Quality ...responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to,… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …- eg, Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance , Regulatory, and Project Management Office - to ... maintain acceptable inventory levels. + Coordinates interdepartmental activity with Quality Assurance , Manufacturing, Engineering and Contract Administration. +… 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
- CSL Behring (King Of Prussia, PA)
- …in ensuring seamless integration of agile planning, collaboration, documentation, and quality assurance processes aligned with enterprise goals and regulatory ... **The Opportunity** Reporting to the Associate Director , Testing Center of Excellence and I&T Tools,...and prioritize enhancements. Ensure alignment with regulatory standards (eg, GxP , audit readiness) while actively owning and managing change,… more
- Charles River Laboratories (Cleveland, OH)
- …operational area + Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with oversight + ... with oversight the completion of laboratory investigations, assay troubleshooting and quality observations + Assist in problem solving for technical and/or… more
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance audits + Work collaboratively with ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more
- AGTC (Alachua, FL)
- …programs. * Work with colleagues from the Manufacturing, Analytical Development and Quality Assurance functions to develop process(es) for receiving and ... Management and Stability coordinator will report directly to the Director or Head of Quality Control or...five plus (5+) years of experience working in a GxP environment. * Proficient with Microsoft Office Suite, Project… more
Related Job Searches:
Assurance,
Director,
Director Quality,
Director Quality Assurance,
GxP,
Quality,
Quality Assurance