Job Description

About This Role:
As the Head of External and International Quality, you will be responsible for developing and implementing a global strategy for Quality Assurance oversight across all Biogen markets, including the US. You will also collaborate closely with quality counterparts in indirect markets where Biogen products are commercialized and distributed via marketing partnerships.
In this role, you will oversee and lead the International and US External Manufacturing Quality teams, which include supply chain, quality engineering, quality systems, management review, and product release groups. You will be responsible for the technical release of all products manufactured by contract manufacturing organizations (CMOs), including Qualified Person (QP) release where applicable. You will have final decision-making authority regarding the discontinuation of contract manufacturing facilities or vendors due to compliance issues and will escalate quality concerns with proposed solutions, ensuring effective implementation of resolutions.
Cross-functional collaboration is essential, and you will work closely with internal stakeholders such as Planning, Logistics, External Manufacturing, Manufacturing Sciences, Quality Control, Regulatory Affairs, Patient Services, and Risk Management to maintain compliance with global regulatory standards. Additionally, you will provide Quality expertise to both internal and external partners in areas like Technology Transfer, Validation, Manufacturing, Investigations/CAPA Management, Change Control, and Risk Management.
What You'll Do:

• Build and maintain strong relationships with internal partners to ensure Global Quality goals and objectives are achieved.
• Lead and participate in cross-functional teams on product investigations, regulatory audits/inquiries, implementation of new/revised GxP guidelines, and strategic improvement initiatives.
• Negotiate Quality Agreements with CMOs and corporate partners.
• Participate in Health Authority audits, support audits at contract sites, and oversee inspections at Affiliates.
• Manage Commercial Quality initiatives related to GxP systems and procedures to support new affiliate operations and licenses.
• Maintain effective relationships with external partners and affiliates to ensure adherence to Biogen standards, GMPs, and regulatory guidelines.
• Ensure compliance with Swiss Ordinance requirements (812.212.1) regarding manufacturing, import/export, wholesale, and foreign trade.
• Lead Global Supply Chain and CMO management reviews, ensuring corrective and preventive actions are identified and executed effectively.
• Drive strategic initiatives to re-engineer business processes within Global External Manufacturing Quality, including product disposition decisions (e.g., release to market, regulatory reporting, product withdrawal/recall).
• Recruit, retain, and develop a strong quality team responsible for ensuring compliance at CMOs and Affiliates.
• Oversee the timely technical release of Biogen products, coordinating with global release functions to ensure product availability and on-time product supply.
• Provide technical support and updates to direct reports, set clear expectations, and provide constructive feedback.
• Monitor team performance and behavior, leveraging stakeholder feedback to promote development and empowerment through coaching and management.

Who You Are:
You are an experienced leader with a deep understanding of global Quality Assurance practices in the pharmaceutical industry. You excel at fostering strong relationships with internal and external partners and thrive in dynamic environments where regulatory complexity is a constant challenge. Your strategic mindset enables you to drive initiatives that enhance operational efficiency and compliance. You are committed to developing your team, empowering them to excel in their roles, and cultivating a culture of excellence and continuous improvement.
Required Skills:

• 15+ years of experience in leadership roles preferable in pharmaceutical industry.
• 10+ years of experience in Quality associated with biopharmaceutical / pharmaceutical production.
• Minimum of a Bachelor's degree in Natural Sciences or Engineering.
• Advanced degree (Master's or PhD in Biological Sciences) is a plus.
• Experience in people and project management.
• Experience in managing a Global team across multiples sites.
• Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices
• Ability to hire, retain top talent, and develop leaders.
• Ability to influence the organization through consistent execution of Biogen leadership competencies
• Flexible when priorities change
• Strong leadership abilities required to effectively implement change management strategies
• Demonstrated ability to successfully manage conflicts and solve problems.

• Excellent knowledge of pharmaceutical product development processes, and device regulations.

Job Level: Management
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. 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.

Skills Required