Quality and Regulatory Labelling Program Manager
hace 11 horas
Basingstoke
Quality and Regulatory Labelling Program Manager Location: Basingstoke, with occasional on-site attendance required (approximately once per month for meetings) Pay Rate: £27 per hour We are currently recruiting for a Quality and Regulatory Labelling Program Manager to support global labelling quality and regulatory initiatives within a highly regulated environment. This role will focus on ensuring compliant, accurate, and globally harmonised product labelling across international markets while driving continuous improvement and operational effectiveness. This is a 9-month contract with the possibility of an extension. Key Responsibilities: Lead the planning, coordination, and execution of global labelling quality and regulatory initiatives Support compliant implementation of labelling changes, artwork updates, UDI requirements, IFUs, translations, and market-specific labelling obligations Collaborate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Packaging, Supply Chain, and Commercial functions Manage program governance, timelines, deliverables, budgeting, risk assessments, and reporting activities Lead labelling remediation projects, artwork harmonisation initiatives, and compliance transformation activities Coordinate implementation of product labelling changes related to regulatory updates, product modifications, safety notices, recalls, or market expansion activities Support inspection readiness activities and coordinate responses to regulatory observations and internal audit findings Track commitments, corrective actions, and implementation milestones to ensure timely completion and sustained compliance Drive continuous improvement initiatives focused on labelling accuracy, standardisation, compliance, and operational efficiency Ensure labelling processes comply with applicable regulations and standards including FDA, EU MDR/IVDR, ISO, GMP, UDI, and regional market requirements Technical Responsibilities: Apply structured program and project management methodologies to regulatory and labelling initiatives Manage integrated project plans including schedules, resources, dependencies, budgets, and implementation activities Monitor completion of labelling change controls, artwork approvals, remediation activities, and compliance actions Facilitate governance meetings, review boards, audit sessions, and executive reporting activities Maintain audit records, artwork approvals, and version-controlled documentation in accordance with regulatory requirements Support implementation and optimisation of labelling systems, artwork management tools, and compliance reporting platforms Coordinate UDI implementation, product traceability initiatives, multilingual labelling requirements, and IFU updates Identify and mitigate compliance, operational, and supply chain risks associated with labelling activities Leadership Responsibilities: Lead and coordinate cross-functional and geographically distributed teams Build strong working relationships across Quality, Regulatory, Operations, Engineering, Procurement, and Commercial functions Support stakeholders in prioritising activities and managing resource constraints Deliver presentations and updates to senior leadership regarding programme status, compliance risks, and implementation progress Promote a culture of quality, compliance, accountability, and continuous improvement Coach and support project teams on programme management best practices and change management principles Education: Bachelor's and/or Master's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or related field required MBA or advanced degree preferred PMP or equivalent Project Management certification preferred ASQ certifications (CQE, CQA, CMQ/OE) or RAC certification preferred Lean Six Sigma certification preferred Experience: Minimum 7 years' experience managing complex programmes and strategic initiatives Experience within Life Sciences, Medical Devices, Diagnostics, Biotechnology, Pharmaceutical, or other regulated industries preferred Experience with labelling operations, artwork management, change control, audit management, and remediation programmes preferred Strong understanding of product labelling lifecycle management including IFUs, packaging artwork, UDI, translations, and market-specific labelling requirements Experience supporting regulatory inspection readiness and cross-functional transformation initiatives Strong understanding of global labelling regulations and quality standards including FDA, EU MDR/IVDR, ISO, and GMP requirements Experience with process improvement methodologies such as Lean or Six Sigma beneficial Knowledge, Skills & Abilities: Strong programme and project management capabilities including governance, scheduling, reporting, and risk management Strong understanding of labelling operations, regulatory frameworks, and compliance processes Familiarity with labelling systems, artwork management platforms, and electronic document management systems Excellent analytical, problem-solving, and critical thinking skills Strong communication and presentation skills with the ability to engage stakeholders at all levels Proficient in MS Office applications including MS Project, Excel, and PowerPoint Ability to independently manage strategic initiatives within complex matrix organisations Ability to work collaboratively across multiple teams, functions, sites, and regions Strong organisational skills with the ability to manage multiple priorities and deadlines effectively Ability to travel up to 10-30% annually depending on business requirements Brook Street NMR is acting as an Employment Business in relation to this vacancy. 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