Head of Quality, Device and Combination Products

Regulatory Toolkit; Cambridge (MA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Paid vacation and year-end shutdown

12 company paid holidays + 3 personal

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Biogen is seeking a Head of Quality for Device and Combination Products based in Cambridge, MA. This hybrid role leads the global quality strategy across design, development, manufacturing, and lifecycle activities, aligning regulatory requirements with Biogen's quality system to ensure inspection readiness.

You will oversee the Global Quality Device organization, drive continuous improvement, and represent Quality Operations in cross-functional programs, audits, and inspections to support

Qualifications

• Knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR.
• Experience engaging with regulatory authorities and notified bodies.
• Experience in people management (>5 years) and project management.
• Strong understanding of CMO-mediated supply chain activities.

Responsibilities

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

Skills

Quality leadership

Regulatory knowledge

Project management

People management

GxP/regulatory audits

Supply chain understanding

Regulatory authorities liaison

Supplier management

Cross-functional leadership

Education

BS in Chemical Engineering

BS in Mechanical Engineering

Job description

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.

Job Level: Management

Additional Information

The base compensation range for this role is: -

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 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.