Quality Assurance Head-IFB

Job title: Quality Assurance Head-IFB

About the Role The Quality Assurance Head-IFB will lead all QA activities for Sanofi's greenfield insulin project in Beijing, ensuring on-time execution in compliance with project, local and global GMP requirements across conceptional, basic and detailed design, construction and commissioning, CQ/ qualification, validation, and future site operations. This role acts as the Quality Subject Matter Expert (SME) within the project and will develop and execute QA strategies, processes, and documentation to support the end-to-end insulin Drug Substance program.

What You'll Do

• Ensure quality culture, GMP compliance performance, and continuous improvement across all functions and levels for the project and future sites.
• Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Assurance in project execution.
• Deliver quality activities in accordance with IFB planning and project needs, including writing, reviewing, and releasing documentation.
• Lead the development, implementation, and assurance of Quality Management Systems in IFB.
• Lead Third Party Management process, including support for raw material workstreams ensuring quality compliance with Sanofi global quality standards and local regulations.
• Lead the development, implementation, and assurance of quality risk management within IFB.
• Develop, update, and promote Sanofi Global Quality Documentation.
• Support execution of project C&Q&V strategy, plans, and System impact assessment.
• Support the preparation and execution of DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and VMP.
• Ensure the consistency of turnover packages to system owners.
• Support the review/approval of validation protocols and final reports.
• Collaborate with the facility in Frankfurt to maintain benchmark standards and share best practices.
• Ensure regular reporting to IFB Quality Lead and Global Quality Lead.
• Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Assurance deliverables.
• Report on key project deliverables related to Quality Assurance, ensuring timely and effective communication and escalation of quality issues to appropriate management levels.
• Contribute to the Digital strategy and transformation through appropriate communication within the project.
• Support all relevant compliance inspections (Internal audits, Global Audits, Health Canada, FDA, HLfGP), customer compliance inspections, and supplier audit activities.
• Take responsibility for pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups, and ensuring inspection reports reach appropriate management personnel.
• Mentor and guide IFB Team Members in appropriate Quality behaviors, recommending systematic improvements to leadership and supporting risk-based decision-making.
• Ensure adherence to statutory and company-specific occupational safety guidelines, including safety topic communications and safety training based on risk assessments.

What We're Looking For

• Bachelor's degree in Science/Pharmacy or equivalent (required).
• 5-8 years of industry experience in the biopharmaceutical or related regulated industry.
• Practical experience in Quality Assurance in health-regulated industry.
• Knowledge of biologic product license application processes and associated regulatory requirements.
• Experience in pharmaceutical manufacturing including automation, scientific writing, and risk analysis.
• Quality Operation, Quality systems and Quality Risk Management expertise.
• GxP and health-regulated regulations knowledge.
• Experience with continuous improvement methodologies.
• Change management capabilities.
• Cross-functional collaboration skills.
• Strong decision-making abilities.
• People development mindset.
• Negotiation and influential skills.
• Business partnering aptitude.
• Chinese (fluent, written and spoken) and English (fluent, written and spoken).
• Master’s degree in Science (preferred).

Nice to Have

• Master’s degree in Science (preferred).

Compensation & Benefits

• Opportunities for global career growth and development within a large, cross-functional program.
• Rewards package recognizing contribution and impact.
• Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Various other benefits and international exposure within a scalable insulin manufacturing program.