Quality Assurance Operational Support - Expert

Job title: Quality Assurance Operational Support - Expert

• Location: Bogotá

About the job

Our Team:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by 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.

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 comprehensive report content using provided templates CMS

About you

• Experience: Professional experience at least 5 years in data analytics or qualifications-validations within validation departments in the pharmaceutical sector, medical devices, biotechnology...
• You have experience in equipment qualification documentation management: VP, URS, IQ, OQ, PQ.
• You have experience in processes validations: protocols and validation reports.
• Soft & Technical skills: Proficient in leadership abilities, Stakeholder management, Advanced communication skills (written and verbal), Decision-making capabilities, Mentoring and coaching abilities, Proactive problem identification, Conflict resolution, Planning and coordination, Ability to work under pressure, Presentation skills. Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point & data analytics
• Education: Bachelor's degree (preferably in pharmacy, engineering, chemistry, biology, or related field.
• Languages: You have an advanced level of english communication and writing; proficiency in one of the listed languages preferred: Spanish, Portuguese or French

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.

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

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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!