Biogen

Head of Quality, Device and Combination Products

Biogen$130K — $180K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's in Chemical Engineering, Mechanical Engineering, or relevant field.
  • 12+ years of experience in medical device quality, engineering, and packaging, with 5+ years in clinical quality operations/device quality.
  • Extensive knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation.
  • Experience interacting with regulatory authorities and notified bodies.
  • More than 5 years of experience in people management and project management.
  • Strong knowledge of CMO-mediated Supply Chain activities.
  • Proven experience in international matrix environments.

Responsibilities

  • Develop and implement global quality strategies for device and combination products.
  • Lead the global quality team across design, development, and operations.
  • Manage transfers, deviations, investigations, and CAPAs.
  • Ensure a robust Quality Management System (QMS) for lifecycle management.
  • Engage in Health Authority audits and internal management reviews.
  • Oversee GxP activities and provide engineering quality guidance.
  • Drive continuous improvement initiatives for the Device and Combination Product QMS.
  • Represent Quality Operations in cross-functional projects and development programs.

Benefits

  • Medical, Dental, Vision, & Life insurance offerings.
  • Access to fitness and wellness programs, including a reimbursement feature.
  • Short- and Long-Term Disability insurance coverage.
  • Minimum of 15 days of paid vacation and additional year-end shutdown time off.
  • Up to 12 company-paid holidays plus 3 paid personal significance days.
  • 80 hours of sick time each year for use when needed.
  • Paid Maternity and Parental Leave policies.
  • 401(k) program with company match contributions.
  • Employee stock purchase plan available.
  • Tuition reimbursement of up to $10,000 annually for further education costs.
  • Participation in Employee Resource Groups to support community and teamwork.
Full 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

About Biogen

Biogen is a biotechnology company engaged in the development of innovative therapies for neurological and neurodegenerative diseases. Biogen is developing a pipeline of possible medicines in neurology, neuropsychiatry, specialized immunology, and rare illness, and the company is laser-focused on its mission of helping humanity through science and building a healthier, more sustainable, and equitable world.

Biogen Careers

Join Biogen, a leader in biotechnology, and be part of a team that is dedicated to pioneering neurological and neurodegenerative diseases research. At Biogen, our mission is to lead the way in science and medicine, and we offer job opportunities that challenge and reward your professional growth. Work You’ll Do At Biogen, you will contribute to groundbreaking projects that help improve the lives of millions. Our commitment to innovation and leadership in the industry provides a dynamic environment for both seasoned professionals and those at the beginning of their career. With a variety of job opportunities ranging from research and development to marketing and sales, Biogen is where your skills will help shape the future of healthcare. Join our diverse team and embrace the culture of excellence and collaboration that Biogen is known for. Here, every position contributes to our mission, driving us forward with shared purpose and vision. Biogen’s Employment Philosophy We believe in the power of our people and invest in their future. The growth and development of our team members are paramount, which is why we offer robust benefits, diversity training, and career advancement opportunities. At Biogen, leadership and innovation go hand in hand, fostering an environment where you can thrive. Internship and Early Career Programs Kickstart your career with a Biogen internship. Gain invaluable industry experience, enhance your resume, and build a professional network that will serve you throughout your career. Our internships provide a platform to develop your skills and test your knowledge in a real-world setting, preparing you for full-time employment in the biotechnology field. Hiring Process Our hiring process is designed to identify and attract professionals who are passionate about making a difference. From the initial application and resume submission to the interview and final selection, each step is an opportunity to showcase your unique talents and potential. At Biogen, we look for individuals who are curious, creative, and eager to tackle new challenges. Stay Connected Join Our Team Explore the various positions available at Biogen and find the one that best matches your skills and interests. We are constantly looking for individuals who are driven to explore, innovate, and lead. Keep Up to Date Stay informed with the latest career tips, insider perspectives, and industry-leading insights—all from the people who work here. Biogen is not just a company; it’s a community where you can grow, connect, and contribute to exciting, meaningful work. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the rewarding opportunities waiting for you at Biogen and be part of our mission to lead in the biotechnology industry. Join Biogen today and be part of a team that is dedicated to redefining the boundaries of science and medicine. Your career at Biogen is not just a job—it’s a pathway to personal and professional fulfillment.
Learn more about Biogen
Size
9,610 employees
Market Cap
$39.7 billion
Industry
Net Income
$4 billion
Founded
1978
5 Year Trend
-0.8%
Revenue
$13.4 billion
NASDAQ

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