Job title: Manufacturing and Services Senior Specialist Quality Services Product Complaints KL Hub
About the job
Handle and process product technical complaints in compliance with regulatory, QMS, and GxP requirements, ensuring accurate documentation and timely training completion.
Use Korean language expertise to translate and assess complaints while coordinating with cross functional and regional/global stakeholders for investigation and resolution.
Act as a regional hub by triaging complaints, managing urgent regulatory cases, engaging complainants, and ensuring compliant closure or escalation.
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.
Main responsibilities:
Core responsibilities:
1. Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,
biologics, and combination products, ensuring compliance with regulatory standards.
2. Proficient in Korean, facilitating the accurate interpretation and translation of Product Technical Complaints (PTCs) received from the respective countries.
3. Collaborate with internal/external stakeholders via Cross functional teams (Manufacturing
sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field
Alert Reporting, risk management departments, etc.) (as applicable) for complaint
management.
4. Conduct management of complaints into the proper database (as applicable) and perform
assessment, ensuring timely processing as per defined scope. Focus on operational tasks
within the complaint handling process.
5. Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
6. Participate in ad-hoc meetings for product-specific complaint issues and provide timely
feedback to ensure all the data necessary for complaint investigation process.
7. Ensure the compliance of documentation and all Quality processes according to applicable
regulations/ Sanofi standards. Handle Quality Management system (QMS) records by
applying data privacy regulations, manage any discrepancies, and ensure completion within
defined timelines.
8. Ensure the documentation of Hub-related GxP activities.
9. Proactively identify areas for improvement and support on the implementation.
10. Abide any other responsibilities as assigned/aligned by manager.
For MCCQ – Regional hubs
1. Act as a Regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management (as applicable).
2. Determine if the inquiry is associated with an Adverse Event, Pharmacovigilance (PV)
Special Situation, customer service or Field Alert Reporting-related information (as
applicable). Ensure respective teams are communicated, if required.
3. Appropriate handling and closure (as applicable) of information considered as Non-PTC at Regional Level.
4. Capture and document sample information into the proper fields of the system (as
applicable)
5. Ensure to complete all the required information and forward the complaint to Global Hub
(including translation, if applicable).
6. Health authority called-in complaints, prioritized complaints, and suspected counterfeit
complaints are handled with the utmost urgency and in strict compliance with both global
and country-specific regulatory requirement.
7. Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
8. Maintain compliance with all relevant regulatory requirements for complaint management
and reporting.
About you
Why choose us?
Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.
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!