Digital Quality Lead

Start Date: ASAP

End Date: 12-month mission

Location: Antwerpen

Role Overview:

This new role is 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 enhance compliance, particularly around Computerized System Validation (CSV) and Data Integrity (DI), ensuring systems align with regulatory expectations and business needs. The role complements existing CSV/IT teams by focusing on compliance, requirements, and business usage rather than deep technical validation.

Team Environment:

The role is part of the Quality organization (R&D & PV) and collaborates 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.

Typical Responsibilities:

• Review and ensure compliance of GxP systems (GCP, GLP, PV) with regulatory standards.
• Work on CSV documentation (risk assessments, data integrity assessments, validation deliverables).
• Support system lifecycle activities: selection, onboarding, validation, and oversight.
• Collaborate with stakeholders to align systems with business processes and regulatory expectations.
• Assess data integrity risks across systems and ensure controls are in place.
• Participate in investigations, deviations, CAPAs, and inspection-readiness activities.

Experience Required:

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

Must-Have Qualifications:

• Experience in Computerized System Validation (CSV).
• Experience in GCP or Pharmacovigilance (PV) environments.
• Experience in pharmaceutical R&D.
• 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.

Nice-to-Have Qualifications:

• 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.

Work Arrangement:

Hybrid model aligned with organizational standards, with flexibility depending on business needs (no fixed on-site days). Full-time position.

Interview Process:

• Likely 2 interview rounds.
• First round with the hiring manager.
• Second round possibly with a team member.