Job description
Mission
Drive end-to-end GCP/GLP deviation and CAPA management in clinical for a global pharmaceutical R&D and Pharmacovigilance Quality organization. Reinforce a risk- and data-driven quality culture across early development, clinical trials, and post-marketing activities. Be the 7th Compliance Lead in a growing team that ensures inspection readiness and right-first-time practices.
Typical Day
1. Morning triage – review and register new deviations (internal + vendors) in Veeva QMS Source Quality.
2. Root-cause workshops – coach process owners/SMEs to craft robust CAPAs, set timelines, and assign owners.
3. Tracking & effectiveness checks – monitor CAPA progress, design and execute effectiveness checks, escalate slippage.
4. Data storytelling – build KPI dashboards, trend recurrence patterns, and present risk heat-maps to senior stakeholders.
5. Influence & readiness – embed quality mindset with cross-functional teams and external vendors; prep for audits/inspections.
Must-Have
* Solid GCP expertise (GLP/GVP is a plus).
* Proven deviation/CAPA ownership in a validated QMS (Veeva preferred).
* Strong root-cause analysis & risk-based prioritization skills.
* Matrix influencing power and vendor collaboration experience.
* Fluent in French and English mandatory (written & spoken).
Nice-to-Have
* Analytics/KPI dashboard creation, trend analysis, AI/ML notions in quality.
* Outstanding communication, organization, and presentation skills.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.