Job title: Sr. Specialist - Quality Services (Product Complaints)
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.
Global M&S Services acts as a cornerstone to this effort. Our team 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 Global M&S Services Hubs will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.
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. Periodically prepare Key Performance Indicators (KPIs) data for meetings. Support on additional continuous improvement & team initiatives/projects. Create/Review the inquiry, Translate to English (As applicable). Determine if the inquiry is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation, customer service or Field Alert Reporting-related information (as applicable). Ensure respective teams are communicated, if required. Follow up with the complainant for additional information and complaint sample management (as applicable).
- Appropriate handling, review and closure (as applicable) of information considered as Non-PTC. Capture and document sample information into the proper fields of the system (as applicable) Ensure to complete all the required information. Health authority called-in complaints, prioritized complaints, and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. Ensure acknowledgement of Complaint (as applicable). Communicate with the complainant for any other request/ additional information related to complaint, if required.
- Maintain compliance with all relevant regulatory requirements for complaint management and reporting. Categorize Product Technical Complaint (PTC) based on its potential impact on product quality or patient safety as per defined timelines. Recording of complaint details in global system including defective quantity / verify lot number. Categorize and process the Fast track complaint based on defined criteria. Sample management- request for sample collection, update sample/picture information in global system.
- Ensure to complete all the required fields in tools and assign the complaint to respective investigation owning site. Ensure completion of the investigation. Perform final review/update the complaint record and close as per defined timelines. Ensure acknowledgement of Complaint and/or response letter to Complainant (As applicable). Maintain compliance with all relevant regulatory requirements for complaint management and reporting.
About you:
- Experience: Minimum of 5 years of related experience in the pharmaceutical industry. Experience of working on manufacturing sites is an added advantage.
- Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience working on manufacturing sites is an added advantage.
- 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/Pharmaceutical science
- Languages: Excellent knowledge of English language (spoken and written).
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- 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.
- Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas.
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!