Head of External and International Quality

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.

• 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.