Qualification & Validation manager
Synthorx
- Location: Miskolc, Hungary
- Job type: Permanent, Full time
About the job
As Qualification and Validation Manager within our Manufacturing & Supply team in Csanyik, you'll lead critical quality assurance activities ensuring compliance and excellence in our pharmaceutical manufacturing processes. Ready to get started?
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.
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:
- Implement and maintain qualification and validation strategies, plans, protocols, and reports in collaboration with internal and external stakeholders
- Ensure compliance of qualification and validation activities with regulatory requirements and company quality standards
- Maintain systems to properly identify, track, and mitigate compliance and quality risks
- Oversee the execution of process / product validation and qualification for equipment, facilities, and systems
- Establish metrics and KPIs to monitor validation activities, identify trends and conduct periodic reviews
- Lead and manage the qualification and validation team, including hiring, training, coaching, and performance evaluation
- Participate in regulatory inspections and audits, providing quality validation support to site experts
About you
- Experience in validation and qualification activities within pharmaceutical or biotechnology industry will be preferred
- Experience as Quality Assurance, Quality Control and similar
- Education: Master degree: pharmacist, chemist, biologist, mechanical engineer will be preferred
- Technical skills: Proven experience managing qualification and validation projects, including planning, execution, and documentation
- Soft skills: Strong understanding of regulatory requirements (FDA, EMA), excellent communication skills, ability to manage multiple projects simultaneously
- Languages: Fluent in Hungarian and English
Why choose us?
- Shape the future of medicine delivery with cutting-edge technology and AI-driven innovation
- Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.
- Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
#LI-EUR
Pursue progress, discover extraordinary
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!