Responsibilities: Responsible for compliance to Good Manufacturing Practices in areas of responsibility. In conjunction with other functions, design, implement, monitor and maintain the Quality Management System for EML. Team leadership - responsible for regular 1-1 meetings, coaching and review of development opportunities of all direct reports. Develop departmental budget (1 year) and headcount (2-5 year) business plans and to manage expenditure within agreed budgets. Drive technology transfer of products from R&D to manufacturing, ensuring scalability, robustness, and regulatory compliance. Oversee process validation, equipment qualification, and cleaning validation in line with GMP and regulatory requirements. Key player in internal, customer and regulatory audits. Ensure approved technical standard operating procedures (SOPs) are implemented. Technical & routine operational support of EML Manufacturing & Packaging operations, systems & process. Set cross functional objectives and lead cross functional teams to deliver change within the business. Provide Subject Matter (SME) Expertise in Packaging, Material Science & Product Formulation: Plan and execute artwork development, changes and approval in accordance with registered requirements and local requirements. Define and manage packaging and product material changes at EML. Write, review and contribute to module 3 regulatory filings for manufacturing process development and validation. Strategic Legislation review on process and artwork guidance to ensure that there is understanding of the requirements - Risk assessments, PV and CV, Continued Process verification and artwork. Investigation / root cause analysis for deviations, including Corrective Action & Preventative Action (CAPA) plans. Support compliant Critical Device Assessments and Lists for production equipment. Responsible for the management of manufacturing/packaging technical activities (change management, deviation investigation, root cause analysis and complaint investigation). Contribute to the definition and delivery of Quality Risk Assessments. Support Supplier Relationship Management and issue resolution arising from technical and quality performance. Skills and Qualifications: 10 years’ experience in the pharmaceutical or biopharmaceutical industry 5 years in a leadership role, leading and managing a team Bachelors degree in Life Sciences or a related field Applicable technical knowledge and good technical writing ability. Experience in and can apply change management models. Demonstrable familiarity of MHRA/EMA/FDA guidance.