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Randstad Logo Randstad · IT - Administration

Quality And Regulatory Labelling Program Manager

United Kingdom, Basingstoke · Job Posted June 10, 2026
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Job Description

Are you an expert project leader ready to steer high-impact compliance initiatives for a global leader? We are seeking a Quality and Regulatory Labelling Program Manager to lead the execution of enterprise-wide labelling initiatives. In this role, you will ensure compliant, accurate, and globally harmonized product labelling across regulated markets. Operating as an internal program leader, you will partner with global networks across Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, and Marketing. This role is vital for strengthening labelling governance, managing complex change controls, ensuring inspection readiness, and implementing innovative business solutions.

Job Responsibility

  • Program Leadership & Governance: Define program deliverables, timelines, and success metrics for global labelling initiatives. Orchestrate program governance, including labelling review boards, PMO sessions, and change control meetings
  • Regulatory Compliance: Oversee the implementation of product labelling changes driven by regulatory updates, safety notices, or market expansions. Ensure strict compliance with global standards, including FDA, EU MDR/IVDR, ISO, GMP, and UDI requirements
  • Risk & Change Management: Proactively identify and monitor program risks (e.g., labelling errors, supply chain disruptions) and implement mitigation plans. Track corrective actions, commitments, and regulatory milestones
  • Cross-Functional Collaboration: Manage integrated project plans, schedules, and resources across geographically distributed teams. Build strong working relationships across technical and commercial functions to drive alignment
  • Inspection Readiness & Continuous Improvement: Support regulatory inspections and internal audits. Drive process standardization and continuous improvement methodologies to improve operational excellence and workflow efficiency

Requirements

  • Bachelor's and/or Master's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or a related field
  • 7+ years of experience managing complex programs and strategic initiatives
  • Strong background within Life Sciences, Medical Devices, Diagnostics, Biotech, or Pharmaceutical industries
  • Proven experience with labelling operations, artwork lifecycle management, change control, and remediation programs
  • Deep understanding of global labelling regulations and quality standards (FDA, EU MDR/IVDR, UDI, GMP, ISO)
  • Experience supporting product lifecycle management (including IFUs, packaging artwork, translations, and market-specific requirements)
  • Strong track record of leading cross-functional transformation initiatives and regulatory inspection readiness
  • Exceptional program management skills (scheduling, dashboards, business case development, and risk management)
  • Familiarity with enterprise labelling systems, artwork management tools, and electronic document management systems (EDMS)
  • Outstanding analytical, critical thinking, and problem-solving capabilities
  • Excellent written and verbal communication skills
  • Highly proficient with MS Office tools
  • Ability to travel 10-30% annually

Nice to have

  • PMP (or equivalent) project management certification
  • ASQ certifications (CQE, CQA, CMQ/OE)
  • Regulatory Affairs Certification (RAC)
  • Lean Six Sigma certification
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