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This role involves project managing New Product Introduction (NPI) and Post-Launch Product Lifecycle projects across the Barnard Castle site. As part of the Strategy & Business Improvement department, you will work with cross-functional, cross-site, global and external teams at various stages of the product lifecycle to ensure successful delivery of projects with a direct impact on operations and patient outcomes. You will engage with commercial, technical and external partners to coordinate activities, manage resources, and monitor project scope and financial budgeting while maintaining compliance to regulatory standards, GMP, Quality, and EHS requirements. This position operates in a matrix environment without direct report accountability but with significant indirect/project influence.
Job Responsibility:
Project manage and deliver NPI activities including clinical trials, registration, validation and launch of new products
Manage product transfers, line extensions, in licensed products, third party contract manufacturing and GSK business transfers to the Barnard Castle site
Lead multi level teams to manage post launch projects such as market-specific regulatory updates, process changes, equipment upgrades, supplier validations, and site transfers
Develop and monitor project plans and milestones, ensuring timely delivery of all project / program milestones while securing appropriate resources
Represent the Barnard Castle site at cross functional project team meetings, external forums and change management bodies
collaborate effectively with GSK central teams, R&D and external organisations
Coordinate regulatory updates to ensure registered product details are complete, accurate, and supported
Manage lifecycle and NPI changes using project metrics such as Product Transfer Acceptance Criteria and GPS risk mitigation tools to assess effectiveness and identify risks
Build and manage relationships with external partners, suppliers and customers, ensuring negotiated terms align with project delivery goals
Escalate and propose solutions for resource conflicts, capacity issues, supply chain challenges or technical difficulties, liaising with relevant stakeholders and site leadership
Requirements:
Minimum education: GCSEs with demonstrated project management knowledge
Proven experience in project management and managing cross-functional, matrix teams (up to 20 members)
Strong ability to manage project lifecycle activities post-launch and coordinate regulatory actions impacting global market approvals
Excellent stakeholder management, influencing and cross functional collaboration
Nice to have:
Degree in Science or Engineering
Familiarity with project management tools/techniques
Knowledge of sterile product portfolio, technology transfer and commercial operations
Significant relevant hands-on experience with successful delivery of NPI projects or major lifecycle changes
Familiarity with global regulatory market requirements (US, EU, RoW) for product registration, compliance and commercialization
Experience in negotiating commercial terms with external manufacturers/service providers (legal/procurement)
Strong ability to coach and mentor junior team members in project management disciplines
Experience with compliance governance, EHS standards and periodic re-validation cessation processes