Quality Assurance Lead - Deviation & Change Control

Quality Assurance Lead - Deviation & Change Control Start date: ASAPDuration: 6 months + extensionsLocation: Fully remote We are seeking an experienced Quality Assurance Lead to direct and coordinate end-to-end deviation investigations, root cause analyses, and quality risk management processes across global site operations. This role acts as a primary liaison between Business Support Operations (BSO) and multi-country stakeholders to ensure strict adherence to GxP standards, timely record closure, and continuous audit readiness within the Quality Management System (QMS). Key Responsibilities:Lead end-to-end deviation investigations within the enterprise QMS, applying standard Quality Management principles and GxP standards.Serve as the primary point of contact between the BSO team and site/global stakeholders for all assigned deviations.Ensure timely initiation, progression, and closure of deviation records in alignment with established compliance timelines.Drive Root Cause Analysis (RCA) using structured investigation methodologies in collaboration with technical and operational teams.Manage Corrective and Preventive Action (CAPA) life cycles: initiate, assign, track, and close records while ensuring thorough Effectiveness Checks (EC) are completed prior to closure.Coordinate Change Control records: initiate, execute, and close actions linked to deviation outcomes and CAPA implementations.Maintain complete, accurate, and audit-ready QMS records at all times.Support regulatory inspection and internal audit readiness for deviation, CAPA, and Change Control workflows. Qualifications & Experience:Experience: 5–8 years of direct experience in deviation management, root cause analysis RCA, and change control leadership across cross-functional and international teams.QMS Expertise: Deep understanding of Quality Management Systems, GxP regulations, and global quality compliance frameworks.Stakeholder Management: Proven track record of managing complex quality records involving diverse international sites and multi-country stakeholders.Tools: Hands-on proficiency with electronic Quality Management Systems (eQMS) for handling deviations, CAPAs, and change controls.