Quality Systems PMO Program Manager

• Program Leadership & Governance: Define program deliverable, timelines, governance structures, and success metrics for global QMS harmonisation initiatives. Orchestrate PMO reviews, steering committee meetings, and quality councils
• QMS Integration & Harmonisation: Drive the integration of Distribution Centres and supplier quality processes into enterprise QMS frameworks. Support the standardisation of core quality processes including CAPA, Change Control, Document Control, Training, Audit Management, and Complaint Handling
• Risk & Change Management: Identify, monitor, and mitigate program risks such as compliance gaps, operational disruptions, and integration challenges. Build alignment across business units to drive the adoption of harmonised standards and operating models
• PMO Metrics & Reporting: Coordinate enterprise-wide inputs to build standardised reporting, KPI visibility, governance dashboards, and actionable quality insights for senior leadership
• Inspection Readiness & Continuous Improvement: Lead cross-functional remediation and quality transformation initiatives to support regulatory inspections and internal audits. Use Lean, Six Sigma, and operational excellence methodologies to drive process optimisation and simplification

• 7+ years of experience managing complex global Quality Systems, PMO, or enterprise transformation programs
• Proven background within highly regulated industries such as Life Sciences, Medical Devices, Diagnostics, Biotechnology, or Pharmaceuticals
• Strong experience with enterprise QMS harmonisation, quality systems integration, and operational transformation
• Demonstrated experience integrating Supplier Quality, Commercial QMS, Manufacturing Quality, or Distribution Quality processes
• Experience supporting regulatory inspections, remediation programs, and compliance transformation initiatives
• Background using Lean, Six Sigma, PPI, or other continuous improvement methodologies is preferred
• Strong knowledge of Quality Management Systems, enterprise quality governance models, and digital quality software platforms
• Deep technical understanding of core quality processes (CAPA, change control, audits, supplier quality, training, and document management)
• Strong understanding of global quality regulations and standards including FDA, ISO 13485, GMP, and GDP
• High-level stakeholder management and executive communication capabilities, with experience developing governance frameworks, dashboards, and KPIs
• Exceptional change management and organisational transformation capabilities within complex, fast-paced matrix organisations

Background using Lean, Six Sigma, PPI, or other continuous improvement methodologies is preferred