Digital Quality Lead
Location: Walloon Region (hybrid working model)
Engagement: 12-month freelance engagement (ASAP start)
Find out more about this role by reading the information below, then apply to be considered.
Overview
We are partnered with a global pharmaceutical organisation to support the build-out of their Quality R&D & Pharmacovigilance function. This is a newly created Business QA role focused on oversight of GxP computerized systems, with a particular emphasis on Computerized System Validation (CSV) and Data Integrity. The position sits at the intersection of Quality, IT, and business teams, ensuring systems are compliant, fit for purpose, and aligned with regulatory expectations.
Responsibilities
* Provide QA oversight of GxP systems across GCP, GLP, and PV environments
* Review and contribute to CSV deliverables (risk assessments, validation documentation, DI assessments)
* Support the full system lifecycle, from selection and onboarding through to validation and ongoing compliance
* Partner with IT, QA, and business stakeholders to align system usage with regulatory requirements
* Assess and mitigate data integrity risks, ensuring appropriate controls are implemented
* Contribute to investigations, deviations, CAPAs, and inspection-readiness activities
Hard Skills
* Proven experience in Computerized System Validation (CSV)
* Background in GCP and/or Pharmacovigilance environments
* Prior experience within pharmaceutical R&D
* Strong knowledge of GxP frameworks (GLP, GCP, GVP)
* Solid understanding of Data Integrity principles (ALCOA+, data lifecycle, audit trails)
* Fluent in English xjecrpw
Soft Skills
* Ability to work autonomously and manage multiple stakeholders
* Strong critical thinking and problem-solving capability
* Confident communicator, able to bridge technical and business teams
* Detail-oriented with a compliance-first mindset
Qualifications
* Approx. 3–5 years' relevant experience (medior level)
* Degree in a scientific or related discipline (Master's preferred)
* Experienced working in cross-functional, regulated environments