ExecutiveFull TimeEN
Job title职位名称: China EM&S Quality Head
About the job工作职责
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main responsibilities职责描述：
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
1. Quality and Compliance:
Quality Management System:
• Define, implement & maintain Quality Management Systems for EM&S China products
• Ensure compliance with NMPA GMP requirements, China volume-based procurement policies, and Sanofi GOPs
• Manage local regulatory requirements specific to China's biologics manufacturing regulations
• Oversee implementation of quality systems specific to large molecule manufacturing
CMO Oversight:
• Perform risk ranking for CMOs as per Sanofi Directive with special consideration for biologics capabilities
• Monitor CMO compliance with China's NMPA requirements and biologics manufacturing standards
• Identify and mitigate risks related to CMO compliance including small molecules, large molecules and biological product manufacturing
• Track CMO performance through KPIs
Quality Agreement:
• Establish Quality Agreements between Sanofi and CMOs incorporating China-specific requirements
• Ensure agreements address biological product manufacturing requirements
Technology Transfer:
• Manage technology transfers including small molecules, large molecules and biological products
• Ensure compliance with NMPA technology transfer guidelines
• Oversee analytical method transfers
2. Regulatory and Compliance
Product Dossier Management:
• Manage product dossiers according to NMPA requirements
• Ensure compliance with China's regulations
• Oversee product registration requirements
Regulatory Compliance:
• Maintain regulatory status at External Manufacturing sites per NMPA guidelines
• Handle regulatory queries for both chemical and biological products
• Stay current with evolving NMPA regulations and volume-based procurement policies
3. Projects and Business Development
• Support CMO selection including small molecules, large molecules and biological product manufacturing capabilities
• Participate in due diligence activities for new partnerships in China
• Evaluate technical capabilities of potential CMOs
4. Team Management
• Build and lead a qualified quality team with biologics expertise
• Ensure team development in both small and large molecule quality oversight
• Provide technical guidance on biological product quality matters
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。
Knowledge, Skills & Competencies:
• Expert knowledge of NMPA regulations and guidelines, particularly for biological products
• In-depth understanding of biologics manufacturing and quality control processes
• Experience with biological product technology transfers
• Native-level Mandarin Chinese proficiency (written and spoken)
• Excellent English communication skills
• Strong leadership and stakeholder management capabilities
Qualifications:
• B.Pharm/ M.Pharm / Ph.D/ MS/ MSc in relevant field
• 15-20 years total experience in the Pharmaceutical Industry
• Minimum 10 years in Quality Function with demonstrated experience in biologics
• At least 5 years' experience managing quality systems for large molecules and /or biological products in China
• Experience with NMPA inspections and regulatory interactions
• Proven track record of successful CMO management in China
Why choose us?
Pursue Progress. 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 video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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!