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Quality System & Digital Transformation Manager - VIE Contract

Synthorx

Synthorx

Quality Assurance
Prague, Czechia
Posted on Friday, June 7, 2024

Quality System & Digital Transformation Manager - VIE Contract

Location: Czech Republic, Praha

Target start date: 01/10/2024

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Quality System & Digital Transformation Manager VIE in our Quality team you will manage Quality System & digital transformation ensuring entity compliance to GxP, local regulations and Sanofi requirements, including importation and distribution of active ingredients activities and complaints management, reporting directly to Quality Center of Excellence Head.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

  • Manage customer complaints and temperature excursions, coordinating investigations with Contract Manufacturing Organization (CMO) and escalating to relevant stakeholders when needed.
  • Provide inputs for the annual review of supplier and service provider performance.
  • Monitor and maintain CMO, supplier, and third-party qualifications, ensuring availability of quality and safety reports, Permitted Daily Exposure (PDE), ICHQ3D, and nitrosamine topics.
  • Maintain EM&S GenMed Europe quality documentation using Sanofi CMS, implementing global Sanofi documentation.
  • Coordinate and follow up on the quality onboarding and training of newcomers, and off-boarding when relevant.
  • Implement global Quality Management System tools, manage master data, lead change control committees, and support audits and inspections.
  • Identify opportunities for quality assurance improvements and contribute to the digital transformation of Quality & Regulatory department operations.

About you

Experience:

  • Experience in quality assurance, quality control, or quality systems management in a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
  • Proven experience in managing or implementing digital transformation projects within a quality or regulatory context.

Soft and Technical skills:

  • Familiarity with quality management systems (QMS), digital tools and platforms, data analytics, and enterprise resource planning (ERP) systems
  • Strong project management skills with a track record of leading cross-functional projects and teams.
  • Strong analytical skills to identify trends, perform risk assessments, and develop data-driven solutions.
  • Excellent communication and interpersonal skills to interact with stakeholders at all levels and across different functions.
  • Strong problem-solving abilities to address complex quality issues and implement effective solutions.

Education:

  • Master’s degree in Quality Management, Engineering, Life Sciences, Pharmacy, or a related discipline.

Languages:

  • Fluent English

Why choose us?

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

#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!