Our client, a leading pharmaceutical organization, is seeking a Compliance Lead to drive GCP and GLP deviation and CAPA management. The role focuses on reinforcing a risk-driven quality culture across early development, clinical, and post-marketing research projects.
Triage and register deviations within the quality management system while coordinating root cause analysis.
Negotiate and coach robust CAPA plans with process owners and subject matter experts.
Track progress toward timely closure and design comprehensive effectiveness checks.
Produce KPI and compliance dashboards and perform trend analyses to detect recurrence.
Influence internal and external stakeholders to embed inspection readiness practices.
What are we looking for?
You have 5+ years of experience in the biopharmaceutical industry.
You bring 3+ years of experience in clinical research, specifically within GCP, GLP, or GVP domains.
You possess hands-on experience managing non-compliance, including CAPA, deviation management, and effectiveness checks.
You have experience working with a QMS, such as Veeva.
You bring strong expertise in root cause analysis and risk-based prioritization.
You are fluent in English.
Nice to Haves
Experience with KPI dashboards, trend analysis, and AI/ML concepts.
Strong communication, organization, and presentation skills.