- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality ... NJ office. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as ... Sr. Director , Manufacturing Execution System (MES) (Hybrid in South...with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Tris Pharma (Monmouth Junction, NJ)
- …contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... role in overseeing the development, validation, implementation, and integration of GxP -regulated systems across the organization. This position ensures that all… more
- City of Hope (Duarte, CA)
- …of medicine through cutting-edge research. We are looking for a leader to head the Quality Assurance (QA) in Cell and Gene Therapy Operations. This role reports ... a 100+ person GMP team. You will oversee a Quality Assurance team of 15- 20 people...investigations, corrective and preventive actions, document control, change control, GxP training, compliance of activities within cGMP facilities, and… more
- LanceSoft (Pittsburgh, PA)
- …Position Status Label: Hourly Non-Exempt The Sr. Manager, Research and Development (R&D) Quality Assurance will independently perform the duties of the QA ... Program Lead (PL) role, providing Clinical Quality Assurance oversight of assigned clinical studies,...QA (or designee) *As directed by the GCP QA Director , support QA Vendor Quality Oversight (VQO)… more
- 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
- 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
- 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
- BeOne Medicines (San Mateo, CA)
- …Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance .) + Experience training on CTMS, TMF systems, ... **General Description:** The Associate Director (AD), GCOE Learning and Development responsible for...complete lifecycle of GCO role-based curricula in accordance with GxP requirements. + Ensure curricula accurately reflect current SOPs,… 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
- 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 ... in GXP /QA/regulatory compliant pharmaceutical laboratory environment or Quality Assurance /Regulatory Affairs role (prefer late phase/commercial experience).… more
