Senior Specialist Quality Services (Product Complaints)

Job title:Sr.Specialist - Product Complaints, Hyderabad Hub, Business Operations

Hiring Manager: Head – Quality Services, Hyderabad Hub, Business Operations

Location: Hyderabad, India

% of travel expected: Travel required as per business need

Job type: Permanent and Full time

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 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

• Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.
• 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.
• 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.
• Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections.
• Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.
• Identify and implement continuous improvement opportunities in complaint management.
• Provide regulatory interpretation and guidance to internal teams and corporate partners.
• Manage and oversee the training within the team.
• Perform quality checks on activities, prepare reports, and maintain inspection readiness.

About you

Experience:

• 3 – 7 years of related experience in the pharmaceutical industry.
• 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 of working on manufacturing sites is an added advantage.

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)

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!