Job Description
Quality and Regulatory Labelling Program ManagerLocation: Basingstoke, with occasional on-site attendance required (approximately once per month for meetings)Pay Rate: £27 per hourWe 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 initiativesSupport compliant implementation of labelling changes, artwork updates, UDI requirements, IFUs, translations, and market-specific labelling obligationsCollaborate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Packaging, Supply Chain, and Commercial functionsManage program governance, timelines, deliverables, budgeting, risk assessments, and reporting activitiesLead labelling remediation projects, artwork harmonisation initiatives, and compliance transformation activitiesCoordinate implementation of product labelling changes related to regulatory updates, product modifications, safety notices, recalls, or market expansion activitiesSupport inspection readiness activities and coordinate responses to regulatory observations and internal audit findingsTrack commitments, corrective actions, and implementation milestones to ensure timely completion and sustained complianceDrive continuous improvement initiatives focused on labelling accuracy, standardisation, compliance, and operational efficiencyEnsure labelling processes comply with applicable regulations and standards including FDA, EU MDR/IVDR, ISO, GMP, UDI, and regional market requirementsTechnical Responsibilities:Apply structured program and project management methodologies to regulatory and labelling initiativesManage integrated project plans including schedules, resources, dependencies, budgets, and implementation activitiesMonitor completion of labelling change controls, artwork approvals, remediation activities, and compliance actionsFacilitate governance meetings, review boards, audit sessions, and executive reporting activitiesMaintain audit records, artwork approvals, and version-controlled documentation in accordance with regulatory requirementsSupport implementation and optimisation of labelling systems, artwork management tools, and compliance reporting platformsCoordinate UDI implementation, product traceability initiatives, multilingual labelling requirements, and IFU updatesIdentify and mitigate compliance, operational, and supply chain risks associated with labelling activitiesLeadership Responsibilities:Lead and coordinate cross-functional and geographically distributed teamsBuild strong working relationships across Quality, Regulatory, Operations, Engineering, Procurement, and Commercial functionsSupport stakeholders in prioritising activities and managing resource constraintsDeliver presentations and updates to senior leadership regarding programme status, compliance risks, and implementation progressPromote a culture of quality, compliance, accountability, and continuous improvementCoach and support project teams on programme management best practices and change management principlesEducation:Bachelor's and/or Master's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or related field requiredMBA or advanced degree preferredPMP or equivalent Project Management certification preferredASQ certifications (CQE, CQA, CMQ/OE) or RAC certification preferredLean Six Sigma certification preferredExperience:Minimum 7 years' experience managing complex programmes and strategic initiativesExperience within Life Sciences, Medical Devices, Diagnostics, Biotechnology, Pharmaceutical, or other regulated industries preferredExperience with labelling operations, artwork management, change control, audit management, and remediation programmes preferredStrong understanding of product labelling lifecycle management including IFUs, packaging artwork, UDI, translations, and market-specific labelling requirementsExperience supporting regulatory inspection readiness and cross-functional transformation initiativesStrong understanding of global labelling regulations and quality standards including FDA, EU MDR/IVDR, ISO, and GMP requirementsExperience with process improvement methodologies such as Lean or Six Sigma beneficialKnowledge, Skills & Abilities:Strong programme and project management capabilities including governance, scheduling, reporting, and risk managementStrong understanding of labelling operations, regulatory frameworks, and compliance processesFamiliarity with labelling systems, artwork management platforms, and electronic document management systemsExcellent analytical, problem-solving, and critical thinking skillsStrong communication and presentation skills with the ability to engage stakeholders at all levelsProficient in MS Office applications including MS Project, Excel, and PowerPointAbility to independently manage strategic initiatives within complex matrix organisationsAbility to work collaboratively across multiple teams, functions, sites, and regionsStrong organisational skills with the ability to manage multiple priorities and deadlines effectivelyAbility to travel up to 10-30% annually depending on business requirementsBrook Street NMR is acting as an Employment Business in relation to this vacancy.TPBN1_UKTJ