Job Description
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.
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.
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
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.
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.