Regional Clinical Compliance Director responsible for GCP compliance and oversight at BeOne. Leading improvement strategies and managing regulatory compliance across global clinical trials.
Responsibilities
Responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Medicines Clinical activities.
Provides compliance oversight and quality support to BeOne GCO study teams and ensures regulatory compliance.
Supports timely identification of non-compliance issues and ensures appropriate escalation.
Conducts trend analysis to identify potential compliance risks associated with study delivery.
Leads the development and implementation of internal GCP compliance process improvement strategies.
Requirements
Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline.
Minimum of 14 years of progressive experience in clinical operations roles.
Minimum 14 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
Knowledge of ICH/GCP, regional regulations, SOPs, and Clinical Operations Work Instructions.
Experience in oncology global trials is preferred.
Strong analytical and managerial skills.
Benefits
BeOne offers a competitive salary that aligns with industry standards for clinical compliance roles.
Professional development opportunities to enhance skills and advance career.
Flexible working arrangements to promote work-life balance.
Health insurance and wellness programs to support employee health.
Job title
Regional Clinical Compliance Director – Senior Director
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