Head of Quality, Device and Combination Products

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.

• ✓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

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.

• ✓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.