Regional Qualification Expert

Job title: Regional Qualification Expert

• Location: Bogotá, Colombia.

About the job

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 Regional Qualification Expert within our M&S Services Bogota Hub, will be acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

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?

Main responsibilities:

• Conduct initial data interpretation and verify report accuracy against acceptance criteria

• Define statistical methods for data analysis and ensure adherence to protocols

• Utilize statistical tools to generate data graphs and interpret results

• Collaborate with site-specific Subject Matter Experts (SMEs) to review and discuss analysis outcomes

• Identify and report deviations, assessing their impact on qualification outcomes

• Summarize findings and provide clear interpretations of statistical analysis

• Ensure all reports comply with global and local quality regulations and standards

• Write a comprehensive report using the provided templates for QMS (Quality Management System)

About you 

• Experience: At least 5 years of experience in data analytics or qualifications validations within validation departments in the pharmaceutical sector, medical devices, and /or biotechnology.

• Soft and technical skills: Stakeholder management, advanced communication skills (written and verbal). Decision making capabilities, proactive problem identification, conflict resolution, ability to work under pressure, presentation skills. Experience with Quality systems (Veeva, Kneat), Word, Excel, Power-Point & Data Analytics and process validations: protocols and validation reports.

• Education:  Bachelor's degree in pharmacy (preferably), engineering, chemistry, biology, or related field.

• Languages:  Advanced English level is MUST.

Why choose us?

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. 

• You’ll be part of a truly diverse cross-cultural team and can have real business impact. 

• Flexible working policies, including up to 50% remote work. 

• Private medical care, life and health insurance, and gender-neutral paid parental leave 

• Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. 

• Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. 

Pursue Progress. 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.

To apply under the disability condition, it is necessary to have a certificate issued in accordance with the provisions of the Ministry of Health and Social Protection to comply with the obligations established in Law 2466 of 2025 regarding the hiring of people with disabilities.

If you require any reasonable accommodation or adjustment during the recruitment process, please inform the Talent Acquisition team. This information will be treated confidentially and will not impact your application.

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

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