Quality Systems PMO Program Manager
18 hours ago
Basingstoke
Quality Systems PMO 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 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 initiatives Define programme deliverables, governance structures, timelines, and success metrics Support global QMS integration projects focused on standardising quality processes, governance models, and compliance frameworks Collaborate with cross-functional teams across Quality, Operations, Manufacturing, Distribution, Supplier Quality, Commercial, Regulatory, and IT functions Drive integration of distribution and operational quality processes into enterprise QMS frameworks Oversee implementation of standardised quality processes and harmonised operating models across sites and business units Lead remediation and quality transformation initiatives supporting inspection readiness and compliance improvements Develop communication plans, governance reporting, and executive updates relating to programme progress, risks, and milestones Identify and manage programme risks including compliance gaps, operational disruption risks, supplier quality concerns, and integration challenges Coordinate reporting activities including KPI dashboards, governance reporting, and quality metrics visibility Support development and execution of enterprise quality roadmaps and transformation strategies Drive continuous improvement initiatives focused on process simplification, standardisation, efficiency, and scalability Ensure harmonised QMS processes comply with applicable regulations and standards including FDA, ISO 13485, GMP, GDP, and regional regulatory requirements Technical Responsibilities: Apply structured PMO and project management methodologies across enterprise quality transformation initiatives Track completion of harmonisation milestones, remediation activities, system integrations, CAPAs, and compliance deliverables Facilitate governance meetings, steering committee sessions, quality councils, audit readiness activities, and executive reporting Manage integrated project plans including schedules, budgets, resource allocation, dependencies, risks, and implementation timelines Support issue resolution and proactively mitigate operational, compliance, and integration risks Maintain centralised governance documentation, action trackers, controlled records, and reporting repositories Partner with IT and Digital Quality teams to support implementation and optimisation of enterprise QMS platforms and workflow solutions Support harmonisation of quality processes including CAPA, Change Control, Document Control, Training Management, Audit Management, Supplier Quality, Complaint Handling, and Distribution Quality processes Support regulatory inspections and internal audits related to enterprise QMS effectiveness and operational compliance Utilise Lean, Six Sigma, and continuous improvement methodologies to support sustainable operational improvements Leadership Responsibilities: Lead and coordinate global, cross-functional, geographically distributed teams Influence stakeholders across Quality, Operations, Distribution, Supplier Quality, Commercial, Regulatory, IT, and leadership functions Drive alignment and adoption of harmonised QMS standards and operating models across business units Facilitate decision-making and prioritisation through structured governance and data-driven insights Promote a culture of quality, compliance, accountability, and continuous improvement Coach teams on PMO governance, risk management, change leadership, and transformation execution Collaborate with senior leadership to establish strategic roadmaps, governance frameworks, and enterprise quality priorities Experience: Minimum 7 years' experience managing complex Quality Systems, PMO, or enterprise transformation programmes Experience within Life Sciences, Medical Devices, Diagnostics, Biotechnology, Pharmaceutical, or other regulated industries preferred Strong experience with enterprise QMS harmonisation, quality systems integration, and operational transformation initiatives Experience integrating Supplier Quality, Manufacturing Quality, Commercial Quality, and Distribution Quality processes Experience supporting regulatory inspections, remediation programmes, audit readiness, and compliance transformation activities Strong understanding of global quality regulations and standards including FDA, ISO 13485, GMP, GDP, and related quality system requirements Experience with enterprise quality systems, digital quality platforms, and governance frameworks preferred Experience with Lean, Six Sigma, or continuous improvement methodologies beneficial Knowledge, Skills & Abilities: Strong understanding of Quality Management Systems and enterprise quality governance models Deep understanding of quality processes including CAPA, change control, audits, supplier quality, training, and document management Strong programme and stakeholder management capabilities within matrix organisations Excellent communication, analytical, organisational, and problem-solving skills Experience developing governance frameworks, dashboards, KPIs, and executive reporting structures Ability to drive cross-functional alignment across geographically distributed teams Familiarity with enterprise QMS software platforms and digital quality tools Strong change management and organisational transformation capabilities Ability to manage competing priorities within fast-paced regulated environments Brook Street NMR is acting as an Employment Business in relation to this vacancy. 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