Temperature Excursion Quality Manager

• Job title: Temperature Excursion Quality Manager

• Location: Budapest, Hungary

• Job type: Permanent, full-time

• Hybrid working

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our global Quality team as a Temperature Excursion Quality Manager and you'll be responsible for managing temperature excursions and their impact on Investigational Medicinal Products (IMPs) intended for clinical studies sponsored/managed by Sanofi R&D.

Main responsibilities:

• Provide a global service platform with qualified and trained personnel to handle temperature excursions

• Provide directions on product acceptability for use in cases where temperature is outside the limits of stability statement

• Interact with packaging/distribution sites, clinical study responsibles, project quality stakeholders, and project development experts

• Ensure temperature excursion management complies with Good Practices (GxP) and Sanofi procedures

• Serve as the Key Expert User for TEX (temperature excursion management and recording tool)

• Participate in trend analysis, preparation for inspections, and process improvement

• Maintain associated quality documentation

• Ensure activity coverage on all working days of the year

About you

Experience:

• 2-3 years' experience in CMC, clinical fields, or pharma R&D

• Experience in regulatory/quality documentation management is a plus

• Strong knowledge in Pharma Product Manufacturing, CMC or Clinical Supply Chain processes and deliverables, in GxP regulations

Soft Skills:

• Excellent oral and written communication skills

• Ability to work productively with a broad and diverse group of stakeholders

• Autonomy and proactivity; ability to prioritize tasks

Technical skills: 

• Familiarity with TEX (temperature excursion management and recording tool) is a plus

• Familiarity with document management tools: VeevaVault (QualiPSO), Veeva RIM

• Digital skills

Education: 

• Bachelor of Science (BS) degree

Language(s):

• Fluency in English, enabling seamless communication with global stakeholders

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2023" award winner with flexible home office policy

• 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

• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover Extraordinary 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, or gender identity.

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

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

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