Global Training Compliance- Corporate Quality

Role Summary

As the Global Training Compliance - Corporate Quality, you will oversee the quality and compliance oversight and execution of our global GxP Training process as a member of the Corporate Quality team. This role acts as the Quality Unit for the Global GxP Training process and the Business System Owner for the Veeva Vault Training system, ensuring alignment with regulatory standards and organizational objectives. You will design, implement, and continuously improve the system, collaborate with cross-functional teams to maintain high compliance standards, monitor metrics and KPIs, and escalate issues to senior leadership as needed. You will contribute to audits and inspections and help harmonize training compliance across sites and functions in a global framework. This is a hybrid role based at our offices in Research Triangle Park, NC.

Responsibilities

• Provide quality and compliance oversight to the global GxP Training process
• Lead the maintenance of the Veeva Vault Training system across all Biogen sites
• Act as a liaison between global functions, providing leadership and guidance on day-to-day process issues
• Facilitate regulatory updates assessments and track action plans
• Develop and roll out annual GxP refresher training for PO&T functions
• Ensure system design reflects customer needs for global alignment
• Define and prioritize improvement projects for the GxP Training system
• Document business requirements and collaborate with IT for system enhancements
• Approve system access requests and ensure compliance with training standards
• Establish global metrics for process performance and report to senior leadership
• Manage deviations, CAPAs, and change controls related to training process
• Conduct risk assessments and manage quality risks in the global register
• Present Training process during inspections and audits and implement corrective actions as needed

Qualifications

• Required: Minimum 7 years of experience in a similar role within the pharmaceutical or biotechnology industries
• Required: Diploma, Bachelor’s, or Master’s degree in a scientific field
• Required: Profound knowledge of cGMP requirements and IT quality systems
• Required: Previous experience in Training and/or Learning Development
• Required: Strong project management skills, preferably with lean six sigma certification
• Required: Expertise in Veeva Vault Training or similar IT systems
• Preferred: Experience in global project management
• Preferred: Ability to lead and influence cross-functional teams
• Preferred: Excellent understanding of systems implications for compliant training process

Skills

• Global project management
• Stakeholder engagement and cross-functional collaboration
• Regulatory awareness and ability to navigate audits
• Quality systems knowledge and process improvement
• Veeva Vault Training or equivalent IT systems proficiency

Education

• Diploma, Bachelor’s, or Master’s degree in a scientific field