M&S- Commissioning and Qualification Lead IFB

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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