Listed on Biogen’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
Lead the quality strategy and global team for medical devices and combination products at a major biotech company, from design through lifecycle management. This role suits an experienced quality professional with deep regulatory knowledge and demonstrated leadership in device manufacturing compliance.
Our summary, not Biogen’s wording. The full posting is on their site.
What they ask for
Required
- BS in Chemical Engineering, Mechanical Engineering, or relevant field
- Minimum 12 years medical device quality and engineering experience
- At least 5 years in clinical quality operations or device quality
- Knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation
- Regulatory authority and notified body engagement experience
- 5+ years people management experience
- Project management experience
- CMO supply chain activities understanding
- International matrix environment experience
- Supplier management and negotiation skills
- Process development and validation experience