• Location: Praha, Czech Republic
• Hybrid working
• Remote working acccasional visits to CMO plants
• Job type: 12 months fixed term contract

About the job

We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as CMO Quality Manager within our External Manufacturing Europe Quality Department will be responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacturing, testing, and transport of Sanofi products (Genmed).

Main responsibilities :

• Manage quality events received from CMO and record them in the relevant Sanofi database according to local procedure
• Evaluate the investigation report to ensure that criticality, root cause, impacts and CAPA are properly addressed
• Evaluate the CMO decision regarding the final disposition of the impacted batch(es) and confirm the Sanofi decision to the CMO
• Escalate as risk any quality event requiring it, follow investigations and implementation of action plans
• Manage change change control requests from CMO & evaluate Change Control as quality expert while participating to change control committee
• Prepare the quarterly & annual risk review for CMO and update Sanofi database accordingly
• Support the CMO in case of inspections, and ensure communication with relevant subsidiaries for preparation and action plan
• Support and challenge the CMO regarding KPI's, operational documentation to deliver, CAPA plan &Sanofi audits follow-up, etc.

About you

• Experience: At least 2 years work experience in a pharmaceutical plant in manufacturing or quality positions
• Soft skills: Good communicator and project manager; good organizational skills; proven ability to work across functions and cultures; open minded and flexible
• Technical skills: Excellent cGMP knowledge mandatory
• Education: Pharmacist/Engineer chemist, biochemist or equivalent
• Languages: Fluent in English (Exchanges with affiliates worldwide and CMO based in Europe)

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, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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