Expert, Quality Services (Product Complaints)

About us

At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients.

Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.

~ 43.07Bn€ Net Sales FY23

~90 countries

~ 91K employees

~ 59 manufacturing sites

~ 20 R&D sites

Our Team / Overview

The Regional Hub Manufacturing & Supply (M&S) Services is responsible for delivering and supporting M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Regional Hub M&S Quality Services (Product Complaints) will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes to the Global hub. The Regional Hub Product Technical Complaints team handles intake activities of complaint processing.

Main responsibilities

Common responsibilities:

· Monitoring and management of Verifier community (training, communication, list update) of workflows until the full translation verification activities transferred to hub.

· Accurately translate quality documents from one language to another. This includes ensuring the translation is linguistically and technically accurate, maintaining consistency with Sanofi-specific terminology, and adhering to established quality standards and regulation.

· Conduct thorough quality assurance checks on translated documents, involving review of translated content for accuracy, grammar, style.

· Manage and maintain a centralized terminology database, as it is crucial for consistent and standardized translation.

· 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, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management.

· Ensure to complete all training in a timely manner. · Process intake for complaints and evaluate, ensuring timely processing and closure of the complaints.

· Participate in ad-hoc meetings for product-specific complaint issues and provide feedback on complaint investigations.

· Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines.

· Ensure the documentation of Hub related GxP activities. · Any other responsibilities as assigned/aligned by manager.

· Distribution of inquiry/complaints received within team for further processing. · Facilitate periodic governance meetings with respective stakeholders and creation of presentations, SOPs, and training materials.

· Periodic report downloads from relevant tools to ensure all the complaints are received, processed & closed in timely manner.

· Perform quality checks on PTC activities and support audits/ regulatory inspections.

· Strive for continuous improvement by following standardization, simplification, digitalization to achieve efficiency.

About the Job Other Responsibilities:

· Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management.

· Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable).

· Ensure to complete all the required information and forward the complaint to Global Hub.​

· Ensure acknowledgement of Complaint and/or response to Complainant (as applicable).

· 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.

· Maintain compliance with all relevant regulatory requirements for complaint management and reporting.

· Communicate with the complainant (as applicable) for any other request/ additional information related to complaint and complaint sample.

Requirements/Qualifications

· Minimum 8 – 10 years of related experience in the pharmaceutical industry. · Knowledge of cGMP’s, 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 of working on manufacturing sites is an added advantage.

Education

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

Soft Skills

· Proficient in problem-solving, attention to detail, and organizational skills. · Work in a team-oriented, flexible, and proactive manner.

· Analytical skills and ability to multitask in a stressful environment.

Technical skills

· Technical knowledge on the Product complaints

· Understanding and knowledge on Quality Management System related activities

Languages

English & Mandarin

Fluent in Mandarin (write, speak, read) due the countries that will be supporting, and excellent English communication skill.

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, disability, or gender identity.

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