Quality Manager / Qualified Person deputy

Описание

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.

As Quality Manager within our Quality Team, you’ll - supports the Country Quality Head (CQH) in the implementing and maintaining the Country Quality system, embarking all concerned country functions (responsible for GxP and health-regulated activities), ensuring safe and efficient quality products, with associated information & services are available to meet patients’ and customers’ needs. Ready to get started?

Main responsibilities:

Act as Qualified Person back-up for importing license. Ensure compliant market batch release according to local regulationSupport the CQH to ensure robust system for GxP and health-regulated activities in compliance with Sanofi standards and with applicable local regulatory requirements.Support Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating.Support quality oversight on country local contract manufacturers, distributors and GxP service providers.Act as contact person for local health authorities for topics linked to quality control of product in Ukraine.Support a process for management of GxP documents and records is in place in all GxP processes, considering data integrity principles.Support information sharing, training sessions or programs related to processes under the responsibility of country quality for concerned country associates.Support country regulatory inspections under quality responsibility, GMP regulatory inspection on manufacturing sites, country quality audits and provide support to other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilitiesSupport inspection readiness and continuous quality improvement.Support quality of products is managed according to Sanofi standard and local regulationSupport quality agreements with manufacturers, distributors (internal & external).2 years’ experience with QMS in pharmaceutical industry (distribution and re-packaging experience is advantage).Some experience with Import license is requiredKnowledge of Good Distribution/Manufacturing guidelines/legislation. Knowledge of other GxP guidelines would be an advantage.1 years’ experience with batch release is advantage.University qualification: Completed higher education (master level). Degree in Pharmacy is preferred, other degrees: Chemistry, Chemical Technology and Engineering, Biotechnology and Bioengineering, Biomedical Engineering, Biology or another life science discipline.Analytical skills, ability to communicate with internal and external stakeholders, result-oriented team playerUkrainian and English – advanced level both oral and writtenBring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.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 . Discover .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue and Discover – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. 

Pursue , discover

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 and check out our Diversity Equity and Inclusion actions at !