Manager Quality Services (Product Complaints

Job title:Manager Quality Services (Product Complaints), 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

• 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 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)