Quality Systems PMO Program Manager

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.