Senior Specialist Quality Services - Product Complaints

Job title: Senior Specialist Quality Services (Product Complaints KL Hub)

Location: KL

About the Job 

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.  

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:

• Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
• Proficient in Japanese to allow communication for PTC handling.
• 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.
• 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.
• Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.
• Participate in ad-hoc meetings for product-specific complaint issues and provide timely feedback to ensure all the data necessary for complaint investigation process.
• 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.
• Ensure the documentation of Hub-related GxP activities.
• Proactively identify areas for improvement and support on the implementation.
• Periodically prepare Key Performance Indicators (KPIs) data for meetings.
• Support on additional continuous improvement & team initiatives/projects.
• Abide any other responsibilities as assigned/aligned by manager.
• 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.
• Appropriate handling and closure (as applicable) of information considered as Non-PTC at Regional Level.
• Capture and document sample information into the proper fields of the system (as applicable)
• Ensure to complete all the required information and forward the complaint to Global Hub (including translation, if applicable).
• 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 cou try-specific regulatory requirement.
• Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
• Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

About You

• Minimum a Bachelor’s Degree or Master Degree in Business Administration or related field of study.
• Minimum 1-2 years of professional experience in documentation, (optional: in GxP environment).
• Fluent in Japanese (write, speak, read) due the countries that will be supporting, and excellent English communication skill.
• Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner.
• Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.
• Sufficient skills in Quality DMS, Word, Excel, Powerpoint.

Why choose us?

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.