Director, Quality Risk Auditing and Governance

Title: Director of Quality Risk, Auditing and Governance (Hybrid: Research Triangle Park, NC or Cambridge, MA)

Responsibilities:
- Lead the Quality Risk Management Program and ensure alignment with global regulatory expectations.
- Develop and integrate a quality risk management framework with Biogen’s Quality Management System.
- Partner cross-functionally to identify, assess, and mitigate quality risks.
- Oversee planning, execution, and reporting of audits for sites/affiliates, contract manufacturers, contract test labs, and suppliers.
- Ensure timely resolution of audit findings and drive continuous improvement of audit processes.
- Define/enhance global quality governance structures, processes, and metrics; drive transparency via dashboards and reporting.
- Organize and lead Global Management Review meetings to ensure regulatory compliance.
- Provide actionable insights to senior leadership.
- Manage/develop the team and allocate resources to priorities.

Required Skills/Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 12+ years in pharmaceutical/biotech quality assurance; 5+ years in leadership roles.
- Quality risk management, auditing, and governance experience in a regulated environment.
- Deep GMP regulations and quality systems knowledge.
- Experience with multiple modalities (e.g., biologics, small molecules).
- Leadership, communication, and stakeholder management; ability to analyze complex data and present insights.

Preferred Skills:
- Master’s degree.
- Combination products experience.

Benefits (highlights):
- Medical, dental, vision, life insurance; fitness reimbursement.
- Disability insurance; 15+ days paid vacation + end-of-year shutdown (Dec 26–Dec 31).
- Holidays and sick time; paid maternity/parental leave; 401(k) match; stock purchase plan.
- Tuition reimbursement up to $10,000/year; Employee Resource Groups participation.