CSV Manager (Pharmaceutical)

TL;DR

CSV Manager (Pharmaceutical): Leading Computer System Validation activities within a pharmaceutical environment with an accent on GxP compliance, regulatory standards, and validation lifecycle management. Focus on ensuring operational excellence, managing cross-functional validation deliverables, and supporting audits for regulated systems.

Location: Brussels, Belgium

Company

hirify.global is an independent technology consulting firm providing guidance and solutions across Information Systems, Digital, Telecom, Life Sciences, and Engineering to over 1000 clients globally.

What you will do

• 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, and execution.
• Collaborate with cross-functional teams including QA, IT, and business stakeholders.
• Review and approve validation deliverables, deviations, CAPAs, and change controls.
• Support audits and inspections by providing expert validation documentation and guidance.

Requirements

• 7 to 12 years of experience in Computer System Validation within the pharmaceutical industry.
• Strong knowledge of GxP environments, CSV methodologies, and regulatory standards like FDA 21 CFR Part 11, GAMP5, and Annex 11.
• Bachelor’s or Master’s degree in IT, Engineering, Life Sciences, or a related field.
• Fluent in English and French, both written and spoken.
• Experience working in international and cross-functional environments.
• Strong leadership and stakeholder management skills.

Culture & Benefits

• International and multicultural work environment with teams in over 60 countries.
• Access to training programs and professional certifications.
• Opportunity to explore new technologies in an internal R&D lab.
• Personalized coaching and mentoring from experienced professionals.
• Tailor-made career path aligned with individual growth ambitions.

Hiring process

• Brief virtual or phone conversation to understand motivations and fit.
• Approximately 3 interviews with line managers and team members.
• Potential case study, role play, or technical assessment depending on the role.