Qa csv specialist

Brabant Wallon - Contracting (Permanent Contract or Freelance)

Context of the request :

This is a new role within the Quality R&D & PV organization, focusing on Business QA oversight of GxP computerized systems used in clinical and pharmacovigilance activities. The position aims to strengthen compliance, particularly around Computerized System Validation (CSV) and Data Integrity (DI), ensuring systems are aligned with regulatory expectations and business needs. The role complements existing CSV/IT teams by focusing more on compliance, requirements, and business usage rather than deep technical validation.

Team info :

The role sits within the Quality organization (R&D & PV) and works closely with multiple stakeholders: IT, IT Compliance, Computer System QA, Business QA, and business owners. It is a collaborative and cross-functional environment, acting as a bridge between technical teams and business requirements. The team works in coordination with other CSV teams, with a complementary scope focused on QA review and compliance alignment.

Responsibilities :

• Reviewing and ensuring compliance of GxP systems (GCP, GLP, PV) with regulatory standards.
• Working on CSV documentation (risk assessments, data integrity assessments, validation deliverables).
• Supporting system lifecycle activities: selection, onboarding, validation, and oversight.
• Collaborating with stakeholders to align systems with business processes and regulatory expectations.
• Assessing data integrity risks across systems and ensuring controls are in place.
• Participating in investigations, deviations, CAPAs, and inspection-readiness activities.

Years of experience in the position / total :

• Target: Medior profile (approximately 3–5 years of experience).
• Strong autonomy required (ability to work independently and interact with stakeholders).
• More senior profiles can be considered if within budget.

Must have :

• Experience in Computerized System Validation (CSV).
• Experience in GCP or Pharmacovigilance (PV) environments.
• Experience in pharmaceutical R&D (mandatory).
• Knowledge of GxP frameworks (GLP, GCP, GVP, regulatory requirements).
• Strong understanding of Data Integrity principles (ALCOA+, data lifecycle, audit trails).
• Ability to work autonomously and manage stakeholders.
• Strong critical thinking and problem-solving skills.
• Fluent English (mandatory).

Nice to have :

• Experience across both PV and clinical systems.
• Broader business acumen (beyond purely technical CSV expertise).
• Master’s degree (preferred but not mandatory).
• Experience assessing vendor systems and complex data flows.

Our offer:

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.