Job Description

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 systems

Regulatory & Audit Experience :

• Demonstrated success in facing and leading international regulatory audits (FDA, EMA, WHO, Health Canada, etc.)
• Ability to prepare audit-ready documentation and respond effectively to regulatory observations
• Strong understanding of global regulatory landscape and regional requirements

Leadership & Soft Skills :

• Exceptional leadership abilities with proven track record of building and developing high-performing teams
• Outstanding stakeholder management skills with ability to influence and align diverse groups
• Strong communication skills (written and verbal) in English; additional languages are an asset
• Cultural intelligence and adaptability to work effectively in multicultural, global environments
• Strategic thinking with strong problem-solving and decision-making capabilities
• Ability to work under pressure, manage multiple priorities, and deliver results in fast-paced environments

Preferred Qualifications

• Experience with continuous process verification (CPV) and lifecycle validation approaches
• Knowledge of Industry 4.0 technologies and digital transformation in pharmaceutical manufacturing
• Certification in project management (PMP) or Six Sigma (Green/Black Belt)
• Experience with other digital validation tools and electronic quality management systems (eQMS)
• Previous experience in insulin or other biologics manufacturing environments

What We Offer

• Opportunity to lead a strategic, high-impact project in a world-class pharmaceutical organization
• Collaborative, innovative work environment with global exposure
• Professional development and career growth opportunities
• Competitive compensation and benefits package
• Chance to contribute to life-changing therapies for patients worldwide

Location

• IFB - Project site Beijing, Beijing with limited local & international Travel

Reports To

• Project Execution Lead.

Note : # We are committed to diversity and inclusion. We encourage applications from candidates of all backgrounds and experiences.

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