Teams at Biogen

Lead global IT Quality strategy for Biogen, overseeing GxP governance, system validation, IT change control, AI governance, and data integrity. Build and lead an IT Quality organization, drive inspection readiness and enterprise policy administration, and partner with leadership on controls, risk management, and regulatory compliance.

Lead quality engineering for medical devices and combination products across design control, risk management, and lifecycle. Oversee technical documentation, supplier and testing partner QA, audits, design transfer, regulatory filing support, and continuous improvement of the Quality Management System. Serve as quality SME and cross-functional representative.

This role involves managing EHS and Biosafety programs, conducting risk assessments, leading incident investigations, and ensuring compliance in laboratory operations.