At a Glance
- Tasks: Lead global product labeling initiatives and ensure compliance with regulatory standards.
- Company: Join a leading global scientific organisation focused on innovation.
- Benefits: Remote work, professional growth opportunities, and a collaborative environment.
- Other info: Temporary contract with potential for extension and dynamic career development.
- Why this job: Make a real impact in the diagnostics field while driving quality and compliance.
- Qualifications: Bachelor's degree in a relevant field and extensive experience in quality assurance.
The predicted salary is between 60000 - 80000 £ per year.
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.
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. You 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.
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. Contract: Temporary for min 9 months - possibility of extension.
Manager Labelling Quality & Regulatory in Basingstoke employer: Oxford Global Resources
Join a dynamic and innovative diagnostics organisation that prioritises employee growth and collaboration. As a Global Product Labeling Program Manager, you will thrive in a supportive work culture that values your contributions while ensuring compliance with global regulatory standards. With opportunities for professional development and the chance to lead impactful transformation initiatives, this role offers a meaningful career path in a flexible remote setting with monthly meetings in Basingstoke.
