We are looking for a Global Product Labeling program manager, You will lead the enterprise-wide planning and execution of strategic product labeling initiatives for a global scientific leader. You ensure that all global product labels, packaging artwork, and Instructions for Use (IFUs) comply with strict regulatory standards (FDA, EU MDR/IVDR) without causing supply chain disruptions.
Job Description
We are seeking a Quality Engineer to ensure quality compliance and support operations within a highly regulated environment. In this role, you will provide essential quality oversight through detailed documentation reviews, process monitoring, and close collaboration with cross-functional teams.
ou will directly contribute to delivering life-changing products by maintaining high standards, leading investigations, and driving continuous improvement initiatives
Responsibilities
- Global Governance: Define deliverables, timelines, and metrics for global labeling quality and compliance transformation initiatives.
- Cross-Functional Alignment: Connect Regulatory Affairs, Quality, Operations, Packaging, and Commercial leadership across global matrix teams.
- Remediation & Compliance: Lead labeling remediation programs, artwork harmonization, and updates (UDI, translations, and safety notices).
- Risk & Reporting: Monitor compliance gaps and supply chain disruption risks, providing clear dashboards to senior leadership.
- Inspection Readiness: Ensure continuous compliance and sustainable audit readiness across all labeling processes and systems.
- PMO Execution: Manage integrated project plans, schedules, budgets, and change control steering committees.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of relevant quality assurance/control experience,
- 7+ years managing complex programs and strategic quality initiatives within a matrix organization.
- Strong expertise in product labeling lifecycles, change control, and artwork management.
- Deep knowledge of FDA, EU MDR/IVDR, ISO, UDI, and GMP standards.
- Familiarity with labeling systems, artwork management tools, and MS Project/Excel.
- Certifications (Preferred): PMP, RAC, ASQ (CQE/CQA), or Lean Six Sigma.
- Exceptional stakeholder management, change leadership, and executive communication.
Benefits
- Location: REMOTE meetings attendance would be required- 1x month in Basingstoke
- Opportunity to lead high-impact transformation initiatives within a growing diagnostics organisation.
- Collaborative and innovative work environment.
- Opportunity for professional growth and long-term career development.
- Working hours: 40 hours per week, Monday to Friday
- Salary: £4670 per month
- Contract: Temporary for min 9 months - possibility of extension
- ref number: 27319
