Continuous Improvement Manager

Responsibilities Lead the end-to-end management of GRA's Quality Documentation system within QualiPSO (CMS), ensuring full compliance with Global Quality (GQ) standards and Medical Clinical Country Quality (MCCQ) -specific requirements Define, implement, and maintain the GRA QD System in alignment with GQ standards, MCCQ requirements, and applicable regulatory frameworks including 21 CFR Part 211 and GxP regulations Manage the complete document lifecycle — including creation, revision, approval, distribution, periodic review, and obsolescence — in accordance with QualiPSO procedures Oversee Document Change Request (DCR) management, ensuring changes driven by regulatory updates, process transformations, audit findings, or content improvements are processed accurately and on time Execute and manage periodic review workflows, coordinating SME assessments and delivering verdicts in compliance with QualiPSO requirements Administer workflow management and electronic signature procedures within QualiPSO CMS, ensuring proper routing, review, and approval by authorized personnel Maintain and manage the annual Document Plan for GRA, covering new documents, upcoming periodic reviews, planned revisions, and documents scheduled for obsolescence Provide expert guidance to ensure key regulatory activities and processes are documented and implemented in compliance with GxP regulations Support and advise the Business Process Owner (BPO) network throughout the complete QD lifecycle, acting as a trusted subject matter expert Communicate timely updates on new, revised, and obsolete QDs to internal and external GRA stakeholders. Requirements BS/BA degree in a relevant scientific discipline required 5+ years of relevant experience, with at least 2+ years working in Regulatory Affairs (regionally or globally) 2+ years of experience in GxP Quality system management, with demonstrated hands‑on experience managing Quality Documents through their full lifecycle Advanced proficiency in Content Management Systems (CMS), with direct experience in both document controller and document creator roles within an electronic document management system (preferably Veeva) Working knowledge of 21 CFR Part 211 and applicable GxP regulatory standards governing documentation and records management Demonstrated experience applying quality risk management approaches and continuous improvement methodologies in a regulated environment Excellent time‑management and operational skills including planning, organizing, and the ability to motivate and influence others without direct authority Strong sensitivity for a multicultural and multinational environment Excellent oral and written communication skills — invaluable in communicating with global, cross‑functional, cross‑cultural, and multi‑disciplinary teams Strong analytical skills with the ability to analyze complex information, identify trends, and make data‑driven decisions to improve documentation processes and quality outcomes. #J-18808-Ljbffr