Head of Quality, Device and Combination Products
BiogenAbout the role
About This Role:
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.
What You’ll Do:
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.
Who You Are:
You are a visionary leader with a deep understanding of quality management systems and regulatory standards. Your ability to build strong relationships with internal and external counterparts is exceptional, and you thrive in collaborative environments. You possess a strategic mindset and are adept at navigating complex challenges with innovation and expertise. Your passion for continuous improvement and dedication to compliance drives you to maintain the highest standards of quality. In this role, your resilience and adaptability will be key as you lead teams in a fast-paced, dynamic setting.
Required Skills:
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.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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 benef
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