IT Compliance manager (CSV Manager)
The IT Compliance Manager (CSV Manager) will be responsible for ensuring that computerized systems used in a pharmaceutical manufacturing environment are validated, compliant with regulatory requirements, and maintained in a validated state throughout their lifecycle. The successful candidate must have prior experience working within pharma manufacturing companies, possess a strong understanding of GMP requirements, and be fluent in French. This is a contract position with the possibility of permanent placement.
Key Responsibilities
- Lead and oversee Computerized System Validation (CSV) activities across the site, ensuring compliance with EU GMP Annex 11, Annex 15, and relevant regulatory frameworks.
- Develop, implement, and maintain validation strategies, policies, and procedures for IT systems supporting GMP operations.
- Collaborate with QA, QC, Manufacturing, Engineering, and IT teams to ensure systems are fit-for-purpose and inspection-ready.
- Manage risk assessments, validation plans, test protocols, and reports for new and existing systems.
- Ensure data integrity principles are embedded in system design, operation, and monitoring.
- Support audits and regulatory inspections by providing documentation, evidence, and subject matter expertise.
- Train and mentor staff on CSV requirements, compliance standards, and best practices.
- Monitor system changes, upgrades, and periodic reviews to maintain validated status.
- Act as the compliance liaison for IT projects, ensuring timely delivery aligned with regulatory expectations.
Candidate Requirements
- Education: Degree in Computer Science, Engineering, Life Sciences, or related field.
- Experience:
- 5+ years of experience in IT compliance, CSV, or QA roles within pharma/biotech manufacturing companies.
- Strong knowledge of EU GMP, Annex 11, Annex 15, GAMP 5, and data integrity guidelines.
- Proven track record of managing validation projects for ERP, LIMS, MES, SCADA, or other GMP-critical systems.
- Skills:
- Excellent understanding of system lifecycle management and risk-based validation approaches.
- Strong documentation and technical writing skills.
- Ability to communicate effectively with cross-functional teams and regulatory authorities.
- Fluent in French and English (written and spoken).
- Strong organizational skills with the ability to manage multiple projects simultaneously.
- Personal Attributes:
- Detail-oriented, rigorous, and proactive.
- Comfortable working in a highly regulated environment with strict deadlines.
- Strong leadership and stakeholder management skills.
Additional Notes
This role is critical to ensuring inspection readiness and maintaining the integrity of computerized systems supporting GMP operations. The successful candidate will act as a key compliance partner for IT and Quality, driving continuous improvement in validation and system governance.
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