Director, Quality Risk Auditing and Governance

About This Role:

As the Director of Quality Risk, Auditing and Governance, you will lead a dynamic team dedicated to developing and executing Biogen’s comprehensive Quality Risk Management, Auditing, and Governance programs. This pivotal role involves creating and maintaining a robust quality risk management framework that integrates seamlessly with Biogen’s Quality Management System and other risk management processes.
 

You will oversee internal and external quality audits, ensuring that manufacturing and testing sites, distributors and suppliers meet the highest standards. Your leadership will be critical in establishing and continuously improving Biogen’s quality governance framework, driving transparency and accountability through metrics and reporting. By facilitating the Biogen Global Management Review process, you will ensure compliance with global regulatory requirements and implement proactive risk mitigation strategies. Your contributions are vital to enhancing Biogen's reputation for quality and compliance across the organization.
 

This is a hybrid role that can be based either in Research Triangle Park, NC or Cambridge, MA.
 

What You’ll Do:

• Lead the Quality Risk Management Program, ensuring alignment with global regulatory expectations.

• Develop and integrate a comprehensive quality risk management framework with Biogen’s Quality Management System.

• Partner with cross-functional teams to identify, assess, and mitigate quality risks.

• Oversee the planning, execution, and reporting of audits for Biogen sites, affiliates, contract manufacturers, contract test laboratories and suppliers.

• Ensure timely resolution of audit findings and drive continuous improvement of audit processes.

• Define and enhance quality governance structure, processes, and metrics globally.

• Drive transparency and accountability through regular reporting and dashboards.

• Organize and lead Biogen’s Global Management Review meetings, ensuring regulatory compliance.

• Provide actionable insights and recommendations to senior leadership.

• Manage and develop a team of professionals, promoting a culture of quality and continuous improvement.

• Allocate resources effectively to meet organizational priorities.

Who You Are: 

You are a strategic thinker with a passion for quality and compliance. Your ability to lead and inspire a team is matched by your expertise in quality risk management and auditing. You thrive in a collaborative environment, working seamlessly across functions to achieve common goals. Your strong communication skills enable you to present complex quality topics to executive leadership with clarity and confidence. You are committed to fostering a culture of continuous improvement and accountability, ensuring Biogen's global network aligns with regulatory standards.
 

Required Skills:

• Bachelor’s degree in Life Sciences, Engineering, or related field.

• Minimum of 12 years of experience in pharmaceutical/biotech quality assurance, with at least 5 years in leadership roles.

• Experience in quality risk management, auditing, and governance within a regulated environment.

• Deep understanding of global GMP regulations and quality systems.

• Experience with multiple modalities (e.g., biologics, small molecules).

• Strong leadership, communication, and stakeholder management skills.

• Ability to analyze complex data and present actionable insights.

• Proven track record of collaborating effectively with cross-functional stakeholders.

Preferred Skills:

• Master’s degree

• Experience with combination products preferred.

 

Job Level: Management

Additional Information

The base compensation range for this role is: $192,000.00-$264,000.00