About the job:
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
61 Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
61 Collaborate with internal/external stakeholders via Cross functional teams, Manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management.
61 Ensure to complete all training in a timely manner.
61 Process intake for complaints and evaluate, ensuring timely processing and closure of the complaints.
61 Participate in ad-hoc meetings for product-specific complaint issues and provide feedback on complaint investigations.
61 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.
61 Ensure the documentation of Hub related GxP activities.
61 Any other responsibilities as assigned/aligned by manager.
61 Distribution of inquiry/complaints received within team for further processing.
61 Facilitate periodic governance meetings with respective stakeholders and creation of presentations, SOPs, and training materials.
61 Periodic report downloads from relevant tools to ensure all the complaints are received, processed & closed in timely manner.
61 Perform quality checks on PTC activities and support audits/ regulatory inspections.
61 Strive for continuous improvement by following standardization, simplification, digitalization to achieve efficiency.

Requirements/Qualifications
61 Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
61 Minimum 8 – 10 years of related experience in the pharmaceutical industry.
61 Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.
61 Should be knowledgeable in Quality functions of pharmaceutical industry.
61 Experience of working on manufacturing sites is an added advantage.
61 Proficient in problem-solving, attention to detail, and organizational skills.
61 Work in a team-oriented, flexible, and proactive manner.
61 Analytical skills and ability to multitask in a stressful environment.