CS Validation Governance Lead
Walloon Brabant
Engineering - Testing and QA
Master
Work experience: 7-10
Reference number: 93173
Message Body
You have until Monday Feb 9 at 10:00 AM to submit your profiles. After this deadline, the position will be halted. Initially, only three CVs will be shortlisted.If your CV is rejected, you will be informed via FG. If it remains in “submitted” status without feedback, please note that your profile is still under consideration but not currently among the top three selected.
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Join a fast-paced and innovative environment where your expertise will play a pivotal role in enhancing governance and compliance processes within the biopharma sector. An exciting opportunity awaits for a professional who is eager to lead and develop critical strategies in the realm of validation and oversight.
We are looking for a dedicated CSV Governance Lead who is ready to take on the challenge of establishing and improving Computerized System Validation (CSV) governance.
- You will map existing CSV SOPs and identify gaps to improve processes.
- You define the annual CSV strategy and establish priorities based on compliance needs.
- You review, update, and create SOPs, templates, and governance documents.
- You assess the impact of new regulations including GMP Annex updates and the AI Act.
- You contribute to ongoing initiatives related to AI validation processes and CSA updates.
- You lead discussions with Quality Assurance, External Process Owners (EPOs), and validation teams.
- You ensure inspection readiness by managing documentation and training requirements.
What are we looking for?
- You have a minimum of 8-10 years of experience in CSV or validation-related roles.
- You possess a strong background in Computerized System Validation (CSV).
- You can define processes and governance strategies.
- You demonstrate leadership mindset & autonomy, managing tasks independently.
- You are an excellent communicator with strong stakeholder management skills.
- You have experience in the pharma sector or other highly regulated environments.
- You are fluent in English, with French as a strong plus.
- You are independently proactive and capable of driving CSV governance initiatives.
- You are comfortable advising management and challenging stakeholders diplomatically.
- You hold a degree but specific educational requirements are not mentioned.
- You have French language skills, which is a nice-to-have.
- You have exposure to AI validation or CSA (Computer Software Assurance) topics.
- You are proficient in English, with additional language skills in French as a strong advantage and Dutch as optional.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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