Quality Lead

Job title职位名称: M&S Graduate Program-Quality Lead

• Location工作地点： Beijing 北京

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About Manufacturing & Supply (M&S)

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster, reliably, sustainably and affordably, at the quality levels expected.

About the Program

Your Journey to Manufacturing Leadership Starts Here

The M&S Graduate Program is Sanofi's flagship early career accelerator, designed to fast-track exceptional talent into M&S China's core leadership pipeline. Over 3 years, you will gain cross-regional, cross-functional business immersion across critical M&S operations — building deep operational expertise, strategic thinking, and global perspective through real-world challenges. With industry-leading executive support — including a Site Head as your Career Sponsor and a Global M&S Leader as your dedicated mentor — you will benefit from direct access to M&S China Cluster and Global Business Leaders through regular executive dialogues, a personalized development journey with external professional coaching, and targeted capability building in Digital & AI, critical thinking, and leading change. This is your express lane to becoming a strong successor in M&S China's core leadership team.

Main responsibilities：

Quality control lab operational support & Oversight & continuous improvement

• Perform routine and non-routine analytical testing of raw materials, in-process samples, finished products, and stability samples in compliance with SOPs, GxP, and regulatory requirements
• Support QC laboratory equipment qualification, calibration, and preventive maintenance activities
• Assist in analytical method verification and validation activities under supervision
• Document test results accurately and in a timely manner in full compliance with data integrity standards
• Participate in deviation investigations, root cause analysis (RCA), and corrective/preventive action (CAPA) follow-up
• Contribute to laboratory housekeeping, safety compliance, and 5S/continuous improvement initiatives
• Support trend analysis of QC data and escalate anomalies to senior managers

QC Regulatory Compliance & Inspection Readiness

• Support inspection readiness activities for national and international regulatory agencies (NMPA, FDA, EMEA), learning to implement agency-specific requirements
• Participate in self-audits, global audits, and regulatory inspections, building knowledge of compliance expectations and audit response strategies
• Contribute to the development of a robust contamination control strategy and sterility assurance system for sterile and non-sterile products

Cross-functional Collaboration & Stakeholder Engagement

• Collaborate cross-functionally with Production, Quality Assurance, and Regulatory Affairs teams
• Partner with Production, Quality Assurance, Engineering, and Supply Chain teams to ensure quality control operation align across all manufacturing operations
• Provide QC support during product launches, technical studies, and validation activities, practicing influence without direct authority

Team Development & Quality Culture Building

• Support the training and development of QC team members, building coaching and people leadership skills
• Promote a culture of quality throughout the organization, reinforcing GMP awareness and continuous learning
• Progressively take on people management responsibilities, including performance evaluation and individual development planning by Year 3
• Actively engage in the Early Talent Program's learning curriculum, mentoring sessions, and rotational assessments

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

Education: Master's Degree required in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Life Sciences, or related technical disciplines; top MBA with relevant manufacturing exposure also considered

Experience

• At least 2–3 years of experience in pharmaceutical quality assurance, quality control, manufacturing, or related regulatory/compliance roles — ideally within GMP-regulated environments
• Demonstrated exposure to cGMP operations, quality event investigations (deviations, OOS, CAPA), and regulatory compliance over years of tenure alone
• Experience or strong interest in sterile manufacturing, contamination control, or biologics quality systems is highly valued
• Familiarity with Chinese cGMP (NMPA), FDA, and/or EMEA regulatory frameworks is a strong plus
• Fluency in English required; strong written and verbal communication skills essential for regulatory documentation and cross-functional collaboration

Soft skills

• Collaborate effectively with peers, stakeholders, partners across the organization to positively impact business results.

• Act for innovation, initiating new and improved ways of working.

• Develop teams in anticipation of future business needs.

• LEAN oriented, problem solving & new way of working.

• Open minded and curios to learn new tools.

Technical skills

• In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.

• Know-how in Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure, KNEAT solution is a plus.

What You'll Gain 你会获得

This program is designed to give you an advantage in your leadership career. Here is what you can expect:

• A structured 3-year leadership accelerator with clear milestones, defined rotations, and a guaranteed landing role — no ambiguity about where you are headed
• Real-World Business Immersion: Cross-regional, cross-functional rotations in live business environments, building operational expertise, business acumen, and strategic thinking
• Industry-Leading Executive Support: Dual mentorship from a Site Head and Global M&S Leader, with direct access to top leadership through regular executive dialogues
• Personalized Development: Customized career roadmap, external professional coaching, and targeted capability building in Digital & AI, critical thinking, and leading change
• Express Lane to Leadership: 3-year systematic cultivation positioning you as a strong successor for M&S China's core management team

Why choose us?

• Shape the future of medicine and vaccine delivery through the use of cutting-edge Digital and AI-enabled technology solutions, ensuring seamless launches and a resilient global supply of our medicines and vaccines
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale.
• Be part of world-first initiatives like our Modulus factory, smart factories, AI-driven supply chain solutions, and provide thought leadership to the future of BioPharma manufacturing in ˜2035+.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery
• Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
 

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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