Senior Specialist Quality Services, Product Complaints (German speaker)

• ​Location: Budapest

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.  

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 by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. 

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

Experience: 

• 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

Soft and technical skills: 

• Proficient in problem-solving, attention to detail, and good organizational skills
• Ability to work collaboratively with cross-functional teams in a flexible and proactive manner
• Strong analytical skills
• Agile thinker and learner, adaptable to complex & dynamic environments 

Education: 

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

Languages: 

• Excellent knowledge of English language (spoken and written)
• Excellent knowledge of German language (spoken and written)

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. DiscoverExtraordinary.

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.  

Sector(s):

• Manufacturing, Production
• Quality Assurance
• Business Supporting Centres
• Project Management

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