Manager of Product Complaints

at  Sanofi US

Job title: Manager of Product Complaints
Location: Bogotá, Colombia
About the job
Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Manager within our team, you’ll be responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S.

• Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.
• Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.
• Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.
• Evaluate complaints for severity and risk, ensuring timely review and processing.
• Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites.
• Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections.
• Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations.
• Focus on operational tasks within the compliant handling process. Identify and implement continuous improvement opportunities.
• Provide regulatory interpretation and guidance to internal teams.
• Manage and oversee the training within the department.
• Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness.
• Manages and ensures the compliance of all Quality processes and documentation with applicable regulations and anticipates regulatory evolutions.
• Assess, evaluate, and follow up on product technical complaints, creating final reports and response letters for authorities.
• Generate evaluations for early risk detection and trend analysis, supporting the Drug Safety Officer.
• Participate in creating and presenting presentations, SOPs, and training materials.
• Conducting thorough analyses to identify the root causes of defects reported in customer complaints, utilizing IT tools for data accuracy.
• Comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects.
• Physical examination of returned complaint samples (wherever applicable) to pinpoint the exact nature of defects causing customer dissatisfaction. Collaborating with production and laboratory departments to gather comprehensive field data for investigations.
• Entering all findings diligently into IT systems, ensuring the integrity and conformity of data related to customer complaints.
• Proactively proposing areas for improvement and participating in the execution of identified corrective and preventive actions.
• Writing detailed investigation summaries in English, as required.
  About you
  Experience: 10 – 12 years of related experience in the pharmaceutical industry with 5+ years in Quality Assurance and/or Corporate Quality.
  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 the pharmaceutical industry.
  Experience working on manufacturing sites is an added advantage.
  Soft and technical 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)

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!