Role Profile: QC Validation Lead Position Overview A leading international manufacturer is seeking a high-caliber Quality Control Leader to spearhead the design, commissioning, and operational start-up of a state-of-the-art laboratory facility. This is a strategic "Greenfield" opportunity requiring a blend of technical validation expertise, project management, and team leadership. Key Responsibilities Facility Design & Commissioning: Lead the end-to-end setup of QC laboratories, ensuring layouts and workflows comply with ISO 17025, GMP, and cross-contamination standards. Equipment & Validation: Define User Requirement Specifications (URS) and manage the full qualification and validation lifecycle for all laboratory instrumentation. Systems & Governance: Establish robust Quality Management Systems (QMS), including Change Control, Deviation Management, Risk Assessments, and CAPA protocols based on global best practices. Digital Integration: Oversee the automation of data recording and integration between laboratory systems and enterprise ERP platforms (e.g., SAP). People Leadership: Recruit, mentor, and qualify a high-performing lab team. Develop lean working schedules, competency frameworks, and training matrices to ensure readiness for commercial production. Operational Excellence: Define and track key performance indicators (KPIs) and Statistical Process Control (SPC) to monitor lab performance and product quality. Stakeholder Management: Act as the primary technical liaison for internal project teams, regulatory bodies, third-party laboratories, and certification agencies. Candidate Requirements Education: Degree (Level 8+) in Chemistry, Microbiology, Food Science, Biotechnology, or a related technical discipline. Experience: Minimum of 3-5 years in a Quality Management or Laboratory Leadership role within a highly regulated environment (Food, Medical Device, or Pharma). Start-Up Expertise: Proven track record in laboratory start-ups, including equipment validation (URS through to IQ/OQ/PQ) and method validation. Audit Mastery: Strong experience navigating regulatory, third-party, and international certification audits. Technical Skills: Deep understanding of Food Safety legislation, ISO 17025 standards, and LIMS/SAP environments. Leadership Style: A decisive, "boots-on-the-ground" leader who can motivate a diverse team, manage project budgets, and maintain composure in high-pressure commissioning environments. Core Competencies Exceptional project management skills with a focus on timely delivery. Strong numerical and analytical ability for interpreting complex process data. A continuous improvement mindset (Entrepreneurial/Lean approach). High integrity and a methodical approach to hygiene and quality standards. Skills: Validation Quality Lead Lab GMP ISO