Global Head of Quality — Devices & Combination Products

Biogen, Inc.; Cambridge (MA); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insurances

Employee stock purchase plan

Tuition reimbursement up to $10,000 per year

Job summary

Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support both internal and external audits.

We seek candidates with strong project management skills, extensive experience in medical devices, and a deep understanding of quality systems. A minimum of 12 years of relevant experience is required for this pivotal role.

Qualifications

• Minimum 12 years of medical device quality, engineering, and packaging experience.
• At least 5 years' experience in clinical quality operations and/or device quality.
• Experience in engaging with regulatory authorities and notified bodies.

Responsibilities

• Lead the development and execution of global quality strategy.
• Ensure quality management across all stages from design to lifecycle.
• Support internal, external, CMO audits, certifications, and regulatory inspections.

Skills

Quality management systems

Regulatory standards

Project management

People management

Supplier management

Education

BS in Chemical Engineering or Mechanical Engineering

Job description

Biogen, Inc. is seeking a Head of Quality for Device and Combination Products to lead global quality strategy at our Cambridge, MA headquarters. The role requires a visionary leader to ensure compliance with regulatory standards, oversee quality management, and support both internal and external audits.

We seek candidates with strong project management skills, extensive experience in medical devices, and a deep understanding of quality systems. A minimum of 12 years of relevant experience is required for this pivotal role.