Quality Associate

Job title: Quality Associate

●         Location: Seoul, South Korea

* This is a 1.5 year temporary position.

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:

• Manage product technical complaints, monitor investigation activities, and follow up on outcomes to ensure timely resolution.
• Handle quality events, including deviations, change controls, and CAPA activities.
• Coordinate and support analytical method validation and transfer activities to ensure timely and successful implementation.
• Maintain quality agreements with manufacturing sites and third-party suppliers of products and reference standards.
• Support product release activities in compliance with local regulatory requirements and company quality standards.
• Maintain quality documentation and training records, ensuring they remain accurate and up to date.
• Support the delivery and tracking of GMP and quality-related training activities across the team.
• Support quality audits and inspections, including self-inspections, MFDS overseas GMP inspections, MFDS GIP inspections, and health authority inspections.
• Follow up on inspection observations and corrective and preventive actions (CAPAs) to ensure timely closure.
• Liaise with local health authorities regarding quality-related regulatory requests and commitments.
• Serve as backup for Annual Product Quality Review (APQR) activities.

About you

• Experience: Background in pharmaceutical quality assurance, quality control, or regulatory affairs(2-5 years of relevant experience required)
• Soft and technical skills: Strong attention to detail, analytical thinking, and familiarity with GxP quality systems and complaint/deviation handling processes; able to work independently and collaboratively across cross-functional teams
• Education: Degree in Pharmacy, Chemistry, Life Sciences, or a related field
• Languages: Professional proficiency in English for collaboration with global teams

Why choose us?

• Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease.
• Drive meaningful impact at global scale: our medicines reach more than 100 million people each year.
• Be part of a simpler, digital- and AI-powered business that’s rethinking how we work and engage with the world.
• Turn bold ideas into breakthrough launches, with multiple new therapies planned through 2030 and beyond.
• Stretch your career in a development playground, with opportunities across functions, regions, and the entire product lifecycle.