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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Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !