Senior CSV Manager

Amaris Consulting is looking for an experienced CSV Domain Manager with 7 to 12 years of experience to join our dynamic team in Brussels under a long-term international project. In this role, you will lead Computer System Validation activities within a pharmaceutical environment and contribute to ensuring compliance, quality, and operational excellence across regulated systems.

Your Responsibilities:

• Lead and oversee CSV activities for regulated pharmaceutical systems and applications
• Define and implement validation strategies aligned with GxP and regulatory requirements
• Coordinate validation lifecycle activities including risk assessments, test strategies, execution, and documentation
• Collaborate with cross-functional teams including QA, IT, Business, and external stakeholders
• Ensure compliance with industry regulations such as FDA 21 CFR Part 11, GAMP5, and Annex 11
• Review and approve validation deliverables, deviations, CAPAs, and change controls
• Support audits and inspections by preparing validation documentation and providing expert guidance
• Drive continuous improvement initiatives related to validation processes and compliance standards
• Mentor and support junior team members within the validation domain

Your Profile:

• Bachelor’s or Master’s degree in IT, Engineering, Life Sciences, or a related field
• 7 to 12 years of experience in Computer System Validation within the pharmaceutical industry
• Strong knowledge of GxP environments, CSV methodologies, and regulatory standards
• Hands-on experience with validation of regulated systems, infrastructure, and applications
• Experience working in international and cross-functional environments
• Fluent in English and French, both written and spoken
• Strong communication, leadership, and stakeholder management skills
• Ability to work autonomously while managing multiple priorities in a fast-paced environment

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.