About this role
Job title: Quality Assurance Manager-IFB
About the Role The Quality Assurance Manager-IFB will oversee QA activities for the IFB insulin drug substance facility project in Beijing, ensuring GMP, local and global regulatory compliance throughout all project phases. This role operates with autonomy to implement qualification/validation strategies, manage quality risk processes, and provide guidance to project teams across interfaces.
What You'll Do
- Ensure the project is executed in alignment with Sanofi standards and GMP; provide regular reports to the IFB Quality Assurance Head.
- Develop, implement, and assure the Quality Management System within IFB; support the execution of C&Q&V strategies, plans, and system impact assessments.
- Assist in the preparation and execution of DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols, final CQ reports, and the Validation Master Plan (VMP).
- Interact with all interfaces to share benchmarks and best practices; ensure consistency of turnover packages for system owners.
- Support project cost and schedule tracking within quality assurance and ensure compliance with Sanofi guidelines for cost and scheduling.
- Promote quality culture, GMP compliance, and continuous improvement; conduct quality oversight activities; act as the Quality SME for the project; participate in planning, escalation of risks, mentoring, and digital strategy contributions.
What We're Looking For
- Degree in Science/Pharmacy or equivalent; ideally MSc; 3-5 years of industry experience in biopharma or related regulated industry.
- In-depth knowledge of biologics product license application processes and regulatory requirements.
- Practical experience in Quality Operations, Quality System Management, and quality risk management in health-regulated industry.
- Knowledge of Pharmaceutical Manufacturing with production processing including automation.
- Experience in scientific and technical writing; strong verbal and written communication; innovative thinking.
- Familiarity with strategic planning, risk analysis; cross-functional collaboration; decision-making; leadership; negotiation and influencing; business partnering and communication.
- Technical skills: Quality risk management; Quality systems; Continuous improvement management; GxP and health-regulated requirements; international and FDA experience.
- Languages: International and FDA experience.
Compensation & Benefits
- Salary range not disclosed; USD currency for compensation where applicable.
- Comprehensive health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
- Rewarding, future-focused environment with opportunities for growth and international exposure.