Director, Quality Risk Auditing and Governance
About The Position
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.
Requirements
- 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.
Nice To Haves
- Master’s degree
- Experience with combination products preferred.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
