Expert Compliance & Risk Consultant collaborating with engineering and operations for NERC compliance oversight. Supporting mitigation plans and developing internal controls within utility regulatory framework.
About the role
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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