Quality Project Manager

Descripción del puesto:

* Location: Prague, Czechia
* Job type: Fixed-term 1-year contract, full-time
* Flexible working: Hybrid (3 days in Prague office, 2 days home office)

About the job

As a Quality Project Manager within our External Manufacturing & Supply (EM&S) organisation, you will play a key role in ensuring that quality projects are executed in full compliance with Good Manufacturing Practices, current regulations, Sanofi's global quality standards and established Quality Agreements. Ready to make an impact?

Join our General Medicines - External Manufacturing & Supply team, a global virtual site responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in manufacturing, testing and transporting Sanofi products. You'll contribute directly to ensuring that millions of patients receive high-quality medicines when they need them.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our teams across the world strive to transform the practice of medicine, turning the impossible into possible for patients. We work to protect people from infectious diseases and to provide life-changing treatments for the people who need them most.

Main responsibilities:
* Drive Quality projects implementation and rollouts
* Be the quality representative for transfer & projects managed by the transfer team, for new product launch and for reformulation
* Review and approve validation and stability protocol & report (process, analytic) related to the project under his responsibility
* Prepare the Quality agreement for the new CMO and Product Technical specification
* Participation in the update of documentation (SOP) related to the activity

About you

Experience: experience of at least 2 years in Quality Assurance, on-site (is a plus)

Soft skills
* Ability to work on complex projects in a challenging environment
* Communication & Teamwork
* Problem-solving oriented and thoughtful risk-taking mindset
* Ability to identify situations and issues which need escalation to line management

Technical skills
* Detailed knowledge of cGMP, GDP, ICH regulations and international pharmaceutical regulatory expectations
* In-depth understanding of quality management tools
* A working knowledge of conventional manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficial.
* Experience in API manufacturing would be highly appreciated
* Good knowledge in lean manufacturing: qualifier GPS3 investigator, SMS certification practitioner level is a plus.

Education: MSc in Chemistry or Pharmacy

Languages: English: Fluent Professional practice

Why choose us?
* Shape the future of global pharmaceutical supply by ensuring reliable, compliant delivery of essential medicines
* Work within a highly connected global Manufacturing & Supply network driven by digital, data-enabled and AI-supported innovation
* Help bring life-changing treatments to over 100 million people worldwide every year
* Develop your career within a collaborative, inclusive environment with cross-functional and international growth opportunities
* Benefit from Sanofi's comprehensive wellbeing programs, flexible working options and robust learning & development offerings

#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