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