Chief Quality Leader, Device & Combination Products

Biogen, Inc.; Cambridge (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur.

Fitness reimbursement

Disability insurance

Vacation & holidays

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Parental leave

Job summary

Biogen is seeking the Head of Quality for Device and Combination Products to lead the global quality strategy, overseeing the Device quality organization and quality activities across design, development, manufacturing and lifecycle management from our Cambridge, MA headquarters.

You will drive inspection readiness, regulatory alignment, and continuous improvement, partnering with engineering, supply chain, and external CRO/CMO teams in a fast-paced, matrixed environment.

Qualifications

• BS in Chemical Engineering, Mechanical Engineering, or relevant field.
• 12+ years of medical device quality, engineering, and packaging experience with at least 5 years in clinical quality operations and/or device quality.
• Comprehensive knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation.
• Experience in engaging with regulatory authorities and notified bodies.
• Experience in people management (>5 years) and project management.
• Strong understanding of CMO-mediated Supply Chain activities.
• Experience working in international matrix environments.
• Expert knowledge of supplier management and relations, including negotiation skills.
• Experience with process development and validation.

Responsibilities

• Develop and implement quality business strategies for internal and external device/combination product programs.
• Lead the global quality team supporting design, development, manufacturing, and quality operations.
• Lead and support transfers, deviations, investigations, and CAPAs.
• Ensure execution of a robust, compliant QMS for end-to-end lifecycle management.
• Participate in Health Authority audits and management reviews.
• Ensure oversight of GxP activities and provide quality engineering guidance.
• Lead or support continuous improvement of the Device and Combination Product QMS.
• Represent Quality Operations on cross-functional initiatives and development programs.
• Support internal, external, CMO audits, certifications, and regulatory inspections.

Skills

Quality engineering

Regulatory compliance

Leadership

GxP & CFR

Cross-functional leadership

Project management

Supplier management

Quality systems

Audits

Education

BS in Chemical or Mechanical Engineering

Job description

Biogen is seeking the Head of Quality for Device and Combination Products to lead the global quality strategy, overseeing the Device quality organization and quality activities across design, development, manufacturing and lifecycle management from our Cambridge, MA headquarters.

You will drive inspection readiness, regulatory alignment, and continuous improvement, partnering with engineering, supply chain, and external CRO/CMO teams in a fast-paced, matrixed environment.