Job Description
Quality Systems PMO 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 Systems PMO Program Manager to support enterprise-wide Quality Management System (QMS) transformation and harmonisation initiatives within a highly regulated environment. This role will focus on driving consistent, compliant, and efficient quality processes across global operations while supporting operational excellence and continuous improvement initiatives.This is a 9-month temporary contract with the possibility of an extension.Key Responsibilities:Lead programme management and execution of enterprise QMS transformation and harmonisation initiativesDefine programme deliverables, governance structures, timelines, and success metricsSupport global QMS integration projects focused on standardising quality processes, governance models, and compliance frameworksCollaborate with cross-functional teams across Quality, Operations, Manufacturing, Distribution, Supplier Quality, Commercial, Regulatory, and IT functionsDrive integration of distribution and operational quality processes into enterprise QMS frameworksOversee implementation of standardised quality processes and harmonised operating models across sites and business unitsLead remediation and quality transformation initiatives supporting inspection readiness and compliance improvementsDevelop communication plans, governance reporting, and executive updates relating to programme progress, risks, and milestonesIdentify and manage programme risks including compliance gaps, operational disruption risks, supplier quality concerns, and integration challengesCoordinate reporting activities including KPI dashboards, governance reporting, and quality metrics visibilitySupport development and execution of enterprise quality roadmaps and transformation strategiesDrive continuous improvement initiatives focused on process simplification, standardisation, efficiency, and scalabilityEnsure harmonised QMS processes comply with applicable regulations and standards including FDA, ISO 13485, GMP, GDP, and regional regulatory requirementsTechnical Responsibilities:Apply structured PMO and project management methodologies across enterprise quality transformation initiativesTrack completion of harmonisation milestones, remediation activities, system integrations, CAPAs, and compliance deliverablesFacilitate governance meetings, steering committee sessions, quality councils, audit readiness activities, and executive reportingManage integrated project plans including schedules, budgets, resource allocation, dependencies, risks, and implementation timelinesSupport issue resolution and proactively mitigate operational, compliance, and integration risksMaintain centralised governance documentation, action trackers, controlled records, and reporting repositoriesPartner with IT and Digital Quality teams to support implementation and optimisation of enterprise QMS platforms and workflow solutionsSupport harmonisation of quality processes including CAPA, Change Control, Document Control, Training Management, Audit Management, Supplier Quality, Complaint Handling, and Distribution Quality processesSupport regulatory inspections and internal audits related to enterprise QMS effectiveness and operational complianceUtilise Lean, Six Sigma, and continuous improvement methodologies to support sustainable operational improvementsLeadership Responsibilities:Lead and coordinate global, cross-functional, geographically distributed teamsInfluence stakeholders across Quality, Operations, Distribution, Supplier Quality, Commercial, Regulatory, IT, and leadership functionsDrive alignment and adoption of harmonised QMS standards and operating models across business unitsFacilitate decision-making and prioritisation through structured governance and data-driven insightsPromote a culture of quality, compliance, accountability, and continuous improvementCoach teams on PMO governance, risk management, change leadership, and transformation executionCollaborate with senior leadership to establish strategic roadmaps, governance frameworks, and enterprise quality prioritiesExperience:Minimum 7 years' experience managing complex Quality Systems, PMO, or enterprise transformation programmesExperience within Life Sciences, Medical Devices, Diagnostics, Biotechnology, Pharmaceutical, or other regulated industries preferredStrong experience with enterprise QMS harmonisation, quality systems integration, and operational transformation initiativesExperience integrating Supplier Quality, Manufacturing Quality, Commercial Quality, and Distribution Quality processesExperience supporting regulatory inspections, remediation programmes, audit readiness, and compliance transformation activitiesStrong understanding of global quality regulations and standards including FDA, ISO 13485, GMP, GDP, and related quality system requirementsExperience with enterprise quality systems, digital quality platforms, and governance frameworks preferredExperience with Lean, Six Sigma, or continuous improvement methodologies beneficialKnowledge, Skills & Abilities:Strong understanding of Quality Management Systems and enterprise quality governance modelsDeep understanding of quality processes including CAPA, change control, audits, supplier quality, training, and document managementStrong programme and stakeholder management capabilities within matrix organisationsExcellent communication, analytical, organisational, and problem-solving skillsExperience developing governance frameworks, dashboards, KPIs, and executive reporting structuresAbility to drive cross-functional alignment across geographically distributed teamsFamiliarity with enterprise QMS software platforms and digital quality toolsStrong change management and organisational transformation capabilitiesAbility to manage competing priorities within fast-paced regulated environmentsBrook Street NMR is acting as an Employment Business in relation to this vacancy.TPBN1_UKTJ