M&S- Commissioning and Qualification Lead IFB

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About the role

Job Description : CQV Leader - Large Scale Insulin Project - IFB   Position Overview : We are seeking an experienced "Commissioning and Qualification (C&Q) Leader" to lead validation activities for a large-scale insulin manufacturing project. This role requires a strategic leader with deep technical expertise, regulatory knowledge, and proven ability to manage complex greenfield projects in a multicultural environment.     Key Responsibilities :    Strategic Leadership & Project Management • Lead and oversee all CQV activities for the large-scale insulin manufacturing facility from design through to commercial readiness • Develop and implement risk-based validation strategies aligned with ICH Q9 and regulatory expectations • Build, structure, and manage a high-performing CQV team to execute project deliverables on time and within budget • Drive cross-functional collaboration across Engineering, Quality, Operations, Regulatory Affairs, and external partners • Establish project governance, KPIs, and reporting mechanisms to ensure transparency and accountability   Risk-Based Approach & Compliance : • Apply risk-based methodologies (FMEA, HACCP, risk assessments) to prioritize validation activities and optimize resource allocation • Ensure all CQV activities comply with global regulatory requirements (FDA, EMA, WHO, ICH guidelines) • Lead preparation for and successfully navigate international regulatory inspections and audits • Maintain comprehensive validation documentation and ensure traceability throughout the project lifecycle   Technical Expertise & Execution : • Oversee commissioning, qualification (IQ/OQ/PQ), and validation of facilities, utilities, equipment, and processes for insulin production • Lead Computer System Validation (CSV) activities for critical manufacturing and laboratory systems • Champion the implementation and utilization of  "KNEAT" digital validation platform to streamline CQV workflows and documentation • Ensure validation protocols and reports meet regulatory standards and internal quality requirements • Support technology transfer activities and process validation for insulin manufacturing Stakeholder Management : • Build and maintain strong relationships with internal stakeholders across all organizational levels and functions • Manage external vendors, consultants, and contractors to ensure alignment with project objectives • Communicate effectively with senior leadership, providing regular updates on progress, risks, and mitigation strategies • Collaborate with global teams and navigate multicultural working environments with cultural sensitivity   Required Qualifications :    Education & Experience :  • Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Pharmaceutical, Biotechnology, or related discipline) • Minimum 10+ years of progressive experience in CQV within pharmaceutical/biopharmaceutical manufacturing • Proven experience in greenfield projects, preferably in large-scale biologics or insulin manufacturing facilities • Experience working in multinational companies (MNC) with exposure to global standards and practices   Technical Competencies : • Expert knowledge of risk-based validation approaches** and regulatory guidelines (ICH Q7, Q8, Q9, Q10, FDA 21 CFR Part 11, EU GMP Annex 11, 15) • Extensive experience with KNEAT digital validation platform** for managing CQV documentation and workflows • Strong knowledge of Computer System Validation (CSV) including GAMP 5 principles and data integrity requirements • Deep understanding of aseptic processing, sterile manufacturing, and biologics production (insulin manufacturing preferred) • Experience with validation of utilities (HVAC, WFI, clean steam, compressed air), equipment, and automated syste

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