Executive Director, Corporate Quality
Core
Creating and managing the Global Biogen Quality Management System (QMS) for biologic products, ASOs, small molecule products, gene therapy, devices, and combination products.
Role type
Executive Director, Corporate Quality
Builds
Global QMS, risk assessment processes, audit programs, IT quality systems, and lifecycle management for GxP documentation.
Domain
Pharmaceutical / Biotechnology / Regulatory Compliance
Required skills
Pharmaceutical industry leadership, Quality Assurance/Regulatory organization leadership, FDA/EMEA regulatory agency interaction, cGxP/ISO/ICH/Device regulations expertise, GxP IT systems oversight, GxP document lifecycle management, Technical Product Complaint management, Global Management Review chairmanship, Strategic planning and budget management, Team leadership and talent development
Preferred skills
Advanced degree (PharmD, PhD), Clinical and commercial product experience, Large and small molecule programs, Device and combination products experience, Auditing certification (ASQ)
Technologies
Electronic document management systems, GxP IT computerized systems
Responsibilities
Implement integrated quality systems and standards across US and international manufacturing sites; Develop and maintain risk assessment processes for cGXP systems; Oversee internal and external GxP and ISO audit programs; Oversee GxP IT computerized systems and infrastructure; Manage Technical Product Complaints including root cause analysis and CAPAs; Chair Global Management Review (GMR) and prepare executive-level updates; Interact directly with senior representatives of regulatory agencies (FDA, EMEA); Manage direct reports and managers of managers.
Seniority
Executive Director, Management
