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.
