Job title : M&S Services - Senior Specialist Quality Services - Product Complaints

• Job Grade: L1

• Hiring Manager: Head of Global M&S Services, Business Operations

• Location: Plaza 33, Petaling Jaya, Malaysia

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 Senior Specialist Quality Services (Product Complaints), Kuala Lumpur Hub, Business Operations, you’ll will act as partners to M&S organization 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 + 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.

• 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.

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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.