Head of Quality, Device and Combination Products
About The Position
As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination products. This role involves establishing cross-functional roles and serving as the primary quality representative for drug-device combination engagements. You will oversee the Global Quality Device organization, ensuring quality management across all stages from design to lifecycle activities. Your role is critical in ensuring inspection readiness and aligning regulatory regulations within Biogen's quality system, integrating engineering design and risk management. Your leadership will drive compliance with regulatory and quality standards while fostering continuous improvement, ultimately supporting the uninterrupted supply and compliant lifecycle management of devices and combination products. This is a hybrid-based role to be located at our Headquarters in Cambridge, MA.
Requirements
- BS in Chemical Engineering, Mechanical Engineering, or relevant field
- A minimum of 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.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
