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.