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.
Solliciteren