Manufacturing and Services Senior Specialist Quality Services Product Complaints KL Hub

Job title: Manufacturing and Services Senior Specialist Quality Services Product Complaints KL Hub

• Location: Petaling Jaya, Malaysia.
• Hiring Manager: M&S Services, Lead 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

• Experience: 1-2 Years
• Soft and technical skills:
• Education: Pharma
• Languages: Korean Speaker

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.

• Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet.
• Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably.
•  Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed.
• Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions.
• Advance your career through stretch roles, cross-functional moves, and development opportunities designed to match your ambition.
• Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what’s next.

PursueProgress. 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.