Regional Qualification Senior specialist

• Location: Budapest, Hungary
• Flexible working: hybrid

Our Team:

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.

Global Manufacturing & Supply (M&S) Services 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 Services. The team members of Global M&S Services (Report Issuance) will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established Global Quality processes from the hubs.

The Qualification & Validation Report Issuance team performs report writing, review, documentation, planning, and execution tracking for equipment (re)-qualification, Quality Review for Standard equipment’s across sites.

Main responsibilities:

• Write (re)qualification protocol/report for manufacturing site facilities, utilities and equipments according to their categorization type and requirements
• Takes part in data collection regarding the dedicated site facilities, utilities and equipments
• Check if parameters, operating conditions, and acceptance criteria are defined in the protocol per Standard Operating Procedure. Ensure data integrity and quality rules are correctly captured
• Connect with experts to review and discuss analysis results, determine if the objective of the study has been met. 
• Check the list of deviations and change controls, identify the ones which might have an impact on the qualified status of the facilities, utilities or equipments.
• Define findings, make conclusion after interpretation of all needed data and information
• Ensure that content of the qualification reports complies with regulatory requirements (e.g., FDA, EMA), GxP and company quality standards.
• Cooperate with cross-functional teams (regional manufacturing sites, global and other regional HUBs and specific project teams) to ensure smooth execution of issuance of (re)qualification reports.
• Perform tasks in accordance with Good Manufacturing Processes and Health, Safety, Environment requirements and with the associated instructions, procedures, records related to these tasks.  
• If applicable, translate the manufacturing data package
• Participate continuous improvement initiatives through standardization, simplification, and digitalization of equipment qualification processes

About you:

• Experience: Professional experience in pharma industry (GxP regulated environment)
• Soft 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
• Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point
• Education: Bachelor's degree (preferably in engineering, pharmacy, chemistry, biology, or related field)
• Languages: Excellent English communication and writing, proficiency in one of the listed languages preferred: French, German, Italian, Hungarian.

Be part of something exceptional. Our Budapest Hub has been recognized for workplace excellence, innovation, and our commitment to putting people first. See the full list of our awards at the end of this posting.

• Office of the Year 2025 – Evolution Award
• Our most recent award – Sanofi is recognized for creating an innovative workspace that supports collaboration and adaptability.
• Marketing Diamond Award 2026 – Employer Branding
• One of the highest honours at Hungary's prestigious Marketing Diamond Awards, recognizing excellence in employer branding.
• BSC Investor of the Year 2025
• Awarded by HIPA, ABSL Hungary, and AmCham Hungary for our contribution to Hungary's business services sector.
• PwC Workforce Preference Survey 2025 – Top 3 Most Attractive Employers
• Ranked 3rd among the most attractive employers in Hungary.
• Hungarian Employer Branding Awards 2025 – Gold & Silver
• Best Strategic Employer Branding Campaign (Gold) and Best Employer Branding Campaign in the Pharma Sector (Silver).