About the job

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:
A.          Management of national lot release application
B.          Preparation of summary protocol of imported products to submit to Korean Health Authority
C.          Preparation of batch release dossier and management of batch release
D.          SAP data operation as Quality module
E.          Package materials review
F.           Management of affiliate SOPs
G.          Supporting change control, risk management and recalls
H.          Performing/Supporting self-inspection, regulatory inspection and CAPAs
I.           Management of deviations, including investigation, root cause analysis, impact assessment, and implementation of corrective and preventive actions
J.          Supporting Annual Quality Review and Product Review (PQR)
K.         Management of quality events and non-conformances related to vaccine BU products
L.         Review and approval of quality-related documents for vaccine BU products (protocols, reports, specifications, etc.)
M.       Proactive communication with Korean Health Authorities and manufacturing sites regarding vaccine BU products

2. Management of products technical complaints and CCB (Cold Chain Break) events concerning Vaccine BU products
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

3. Supporting distribution center to ensure that GSP/GMP is implemented in the warehouse
A.          Supporting manager to make usage decisions and salving for defect products
B.          Management of KGSP documents and required regulatory dossiers

4. Ensuring that Vaccine BU products are manufactured, imported or distributed appropriately according to quality system.
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

5. Managing and archiving GxP records, including electronic records in GxP archiving tool and paper records in accordance with RRS (Record Retention Schedule)

6. Managing GxP 3rd parties in compliance with Sanofi process
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.