Job title: Quality Complaint Management Specialist

Location: Bogota, Colombia

Job type: Fixed Term - 6 months

About the job

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 and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

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 Manufacturing & Supply (M&S) Services is responsible for delivering and supporting Global

M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of M&S Quality Complaint Management Services will act as

partners in carrying out tasks and fulfilling responsibilities to support the identified and established

quality processes delivered from the hubs. The Product Technical Complaints team handles end-to- end activities of complaint processing.

Main responsibilities

• Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products,

biologics, and combination products, ensuring compliance with regulatory standards.

• Collaborate with internal/external stakeholders via Cross functional teams (Manufacturing

sites, Customer Service, Medical Information, Pharmacovigilance, Regulatory, Legal, Field

Alert Reporting, risk management departments, etc.) (as applicable) for complaint

management.

• Conduct management of complaints into the proper database (as applicable) and perform

assessment, ensuring timely processing as per defined scope. Focus on operational tasks

within the complaint handling process.

• Ensure to complete all training in a timely manner and guarantee continuous improvement of the knowledge according to the annual training plan.

• Participate in ad-hoc meetings for product-specific complaint issues and provide timely

feedback to ensure all the data necessary for complaint investigation process.

• Ensure the compliance of documentation and all Quality processes according to applicable regulations/ Sanofi standards. Handle Quality Management system (QMS) records by

applying data privacy regulations, manage any discrepancies, and ensure completion within defined timelines.

• Ensure the documentation of Hub-related GxP activities.

• Proactively identify areas for improvement and support on the implementation.

• Abide any other responsibilities as assigned/aligned by manager.

About you

Experience: 1-3 years of related experience in the pharmaceutical industry,, should be knowledgeable in Quality functions of pharmaceutical industry.

Required Skills: Proficient in problem-solving, attention to detail, and good organizational skills, work in a team-oriented, flexible, and proactive manner, analytical skills and ability to multitask in a stressful environment.

Education: Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.

Languages: Excellent knowledge of English language (spoken and written) & Portuguese language (reading and writing).

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!