Job title: M&S Services, Manager Quality Services, Product Complaints Budapest

• Location:Budapest, Hungary 

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Manager Quality Services within our Product Complaints Budapest team, you will be:

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
• 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. Also identify and implement continuous improvement opportunities. Aswell as, 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
• 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. Aswell as, comprehensive review of batch records, correlating relevant manufacturing data with quality events and deviations to elucidate reported defects. Proactively proposing areas for improvement and participating in the execution of identified corrective and preventive actions

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) 

Why choose us?

• 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
  

PursueProgress. 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.

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Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

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