Quality Business Partner

●         Location: Seoul, Korea

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.

A.          Management of PTC (Product Technical Complaint), including receipt, registration, investigation coordination with manufacturing sites, trend analysis, timely closure in compliance with Sanofi global process, and regulatory reporting to Korean authorities (MFDS/KDCA)

B.          Management of cold-chain breaks, including impact assessment and coordination for usage decisions

A.          Supporting manager to make usage decisions and salving for defect products

B.          Management of KGSP documents and required regulatory dossiers

A.          Supporting assessment of sub-contractors’ KPI

B.          Management, archiving and change control of quality documents from manufacturing site

C.          Document archiving and management for imported products

A.      Ensure 3rd party qualification and perform routine management according to the GOP

B.      Performs QRA (Quality Risk Assessment) incl. Market research QRA and manage audit program

C.      Manage and ensure up-to-date QTP Data Base

D.      Ensure appropriate, accurate & up-to-date signed quality agreements are in place.

E. Management of contract laboratories, including:

• Management of test requests and coordination of analytical testing activities
• Reagent Management
• Document management including test reports, SOPs, and related quality records
• Contract management and quality agreement maintenance
• Troubleshooting and resolution of QC issues and out-of-specification (OOS) results
• Qualification and ongoing performance monitoring of contract laboratories

About you

Required(필수)

• Bachelor's degree or above in Pharmacy, Life Sciences, Biology, Chemistry, or a related field
• Minimum 1–3 years of experience in the pharmaceutical or healthcare industry (Quality or a related GxP function)
• Proficient in English, with the ability to communicate effectively in writing and verbally with global manufacturing sites and international teams
• Working knowledge of GxP regulations (GMP, GDP, or GSP) and quality management systems

Preferred(우대)

• Experience in vaccine/pharmaceutical product batch release or lot release operations
• Experience in a QA/QC function at a pharmaceutical industry

Soft Skills / Attitude

• A self-motivated, proactive team player who can manage multiple priorities independently with minimal supervision
• Strong attention to detail with a problem-solving mindset
• Ability to thrive in a fast-paced, cross-functional environment

Why choose us?

●     Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.

●     Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.

●     Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.

●     Share knowledge with leading scientists, engineers, and experts in a purpose-driven community dedicated to protecting millions worldwide.

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!