Head of Global Product Quality- Biologics
Core
Lead global product quality strategy, compliance, and operational execution for Biogen's biologics portfolio, ensuring alignment with GMP guidelines and regulatory requirements.
Role type
Senior management (Head of Global Product Quality)
Builds
Biologics products and regulatory submissions
Domain
Biopharmaceuticals / Biologics / Quality Assurance
Required skills
Strategic planning, regulatory compliance management, team leadership, cross-functional collaboration, specification strategy, audit management, stakeholder influence, trend monitoring, combination product strategy
Preferred skills
Mentoring, innovation in quality practices, navigating international matrix environments
Technologies
GMP, GCP, GDP, ICH regulations
Responsibilities
Lead asset strategy and compliance best practices across products; Review major regulatory submissions and set strategic plans; Execute specification strategy and address agency concerns; Serve as Specification Review Board Chair; Ensure timely completion of Annual Product Review and trend monitoring; Support internal and external audits of CMOs; Represent the company at external forums.
Seniority
Senior, strategic leadership with operational oversight
