Quality and Regulatory Labelling Program Manager
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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, xsngvjr 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.