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In the frame of the growth of our business, we are looking for an:
CSV Manager
Main activities
* Ensure validated status and regulatory compliance of all computerized systems within scope throughout their lifecycle, maintaining full accountability for conformity.
* Deploy and maintain a standardized CSV methodology, and write, review, and update CSV documentation, procedures, and validation deliverables when necessary.
* Manage staff by proactively balancing workload and resources to achieve operational and project goals.
* Actively manage relationships with internal clients and stakeholders, ensuring clear communication, alignment on priorities, and a strong customer-oriented approach.
* Monitor regulatory changes, optimize CSV processes, and provide expertise for technical solution design and implementation.
* Prepare and present validation files for audits, lead investigations and corrective actions in case of non-conformities and execute operational validation tasks when required.
* Audit suppliers in collaboration with Quality teams and represent company interests in compliance-related disputes.
Your profile
* University degree in Engineering, Computer Science, or related field.
* Minimum 10 years of experience in the pharmaceutical and/or medical device industry, including strong exposure to CSV activities.
* Proven project management and leadership skills, with the ability to train, coach, and develop a team.
* In-depth knowledge of CSV processes, GxP requirements, and current regulatory standards.
* Solid experience in system commissioning, qualification, and lifecycle management.
* Excellent communication, organizational, and problem-solving skills, with strong writing abilities for technical documentation.
* Ability to work proactively, adapt to change, and thrive in a dynamic environment.
* Fluent in French and English (written and spoken).
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