Compliance Lead
Location: Geel
About the role
Within the Reliability & Support team, part of the broader Engineering & Maintenance department, you will act as the central point of contact for quality and compliance-related matters. This role calls for a versatile profile that combines technical depth with thorough knowledge of quality processes; this is not a purely theoretical QA function, but a role in which you bridge quality on the one hand and engineering, maintenance and qualification on the other.
A strongly independent and communicatively strong personality is a requirement for this role.
Responsibilities
- You are responsible for drafting and following up on actions within the QMS system (Veeva) of the Engineering & Maintenance department.
- You coordinate the performance of root cause investigations as part of deviations to determine the causal relationship within systems and maintenance processes.
- You prepare change controls in close collaboration with stakeholders such as production, engineering, qualification and quality.
- You support the drafting of robust CAPA plans and ensure the timely periodic review of departmental documentation.
- You support the engineering and maintenance teams with compliance-related documentation and questions.
About you
- Preferably, you have a solid background in qualification, with a strong technical affinity; an essential requirement for this role.
- You have approximately 5 to 10 years of relevant experience in the role.
- You have excellent communication skills and work autonomously within a complex, multidisciplinary environment.
- You have thorough knowledge of the applicable regulations within the pharmaceutical industry (e.g. Eudralex, Annex 1, ICH) and relevant ISPE guidelines.
- Experience with Quality Management Systems within a compliance-oriented function is recommended.
- You take a pragmatic, solution-oriented approach and distinguish yourself through decisiveness rather than a purely theoretical approach.
Languages
Dutch and English.
Why choose Sanofi?
• Transform lives worldwide by helping deliver life-changing treatments, everywhere and always.
• Work with AI, robotics and next-gen automation to redefine the future of manufacturing and supply.
• Grow and thrive in a work environment that encourages you to give your best every day.
• Be part of world firsts such as our smart factories and AI-driven supply chain solutions.
• Develop new skills through cross-functional roles in an environment that values growth and discovery.
• Sustainability at the core: Sanofi invests in people, technology and a low-carbon future.
• Excellent working conditions, including flexible work arrangements, comprehensive healthcare and wellbeing programs.
Pursue Progress. Discover Extraordinary.
Progress does not happen without people – people with different backgrounds, in different locations, fulfilling different roles, all united by one thing: a desire to make miracles happen. You could be one of those people. Pursue change, embrace new ideas and explore all the opportunities we have to offer. Let's pursue progress. And let's discover the extraordinary together.
At Sanofi we provide equal opportunities to everyone, regardless of race, skin colour, origin, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability or gender identity.
See our ALL IN video and check out all the actions at sanofi.com!
What Does Excellence Really Mean in Biopharma? | Making It Real Ep. 2 - YouTube
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But 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. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€67.835,67 - €90.448
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.