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.

• 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.