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.
Pursue
progress, discover
extraordinaryBetter 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!