Our pharmaceutical client has an exciting opportunity for a Technical & Validation Quality Lead to join its team. Job Summary The Technical and Validation Quality Lead serves as a technical quality expert, providing guidance, making quality-related decisions, and supporting validation efforts. This role involves collaborating closely with the quality assurance team, overseeing day-to-day operations, and ensuring quality standards are upheld. Key responsibilities include leading technical investigations, managing customer and supplier quality issues, and ensuring compliance with validation processes. Key Responsibilities & Duties Technical Leadership Lead Quality Assurance Efforts Manage and resolve investigations, including customer responses to technical, product quality, and film coating dispersion complaints. Address quality issues promptly, including assessing non-conformities, supplier concerns, and raw material problems. Lead 8D investigations for the Dartford site to identify and resolve quality challenges. Communicate effectively with customers via written or verbal methods to resolve quality-related issues. Identify areas for improvement within the department and business using audit findings and quality metrics; coordinate with relevant departments to ensure timely implementation. Support Field Force and customer care teams with technical and quality-related queries. Conduct site visits to customers and suppliers to address quality issues and evaluate new systems or processes as needed. Validation and Compliance Validation and Documentation Maintain and update the Site Validation Master Plan, adapting as needed for changes at the Dartford site. Generate new regional Project Numbers specific to the Dartford site. Oversee the Validation Database within the Oracle system, managing updates during and after project lifecycles. Support qualification and validation efforts for QC, plant activities, processes, equipment, and cleaning validation as needed. Review and approve validation protocols and reports (except Global Quality Assurance) before final sign-off. Ensure regional validation SOPs comply with IPEC/ISO standards. Manage the periodic evaluation schedule by updating validation projects in Oracle and tracking the Site Re-Validation Assessment in the Business Intelligence Database. Key Requirements Education: BSc (Hons) in Chemistry, Life Sciences, Food Science, or Materials Science. Ability to understand the science behind the products, their applications, and performance. Communication: Strong written and oral communication skills with the ability to prepare and present technical information. Technical Leadership: Proven track record in leading technical discussions on product quality and making informed decisions. Validation Experience: Experience in validation activities within a healthcare setting, including processes, test methods, cleaning, and FUE. Project Management: Strong project planning and resource management skills, with a focus on prioritization. Team Leadership: Demonstrated leadership and self-development skills with the ability to work within a matrix organizational structure. IT Skills: Proficiency in Excel, Word, and PowerPoint. Travel: Occasional travel required based on business needs. Desirable Skills and Experience Knowledge of IPEC/EXCiPACT and Oracle systems. Experience with Lean methodologies and up-to-date knowledge of cGMP and ISO 9001:2015. Familiarity with the Pharma Industry and standards for manufacturing compliance. Previous experience with FMEA processes and their implementation. Job-Related Skills & Competencies Organizational Skills: Strong organizational abilities with a structured approach to managing workload. Team Player: Ability to work effectively within a team and engage with senior management. Problem Solving: Skilled in identifying and resolving complex quality issues. Communication: Effective communication and influencing skills across all departments. Change Management: Ability to drive continuous improvement and act as a catalyst for change. Presentation: Competent in delivering presentations to various stakeholders. This role is ideal for an individual with a strong scientific background, a commitment to quality, and the ability to lead technical projects within a dynamic environment. £45k - £50k Benefits