Head of IT Quality
$178,000–$245,000 year
Hybrid · Cambridge, Massachusetts, United States or Research Triangle Park, North Carolina, United States
Job Summary
Lead strategic evolution of Biogen's Global IT Quality Management System, covering SDLC, change management, and risk management; ensure validation of IT systems for intended use including AI-enabled systems; provide regulatory inspection readiness and subject-matter expertise on IT Quality, AI governance, and data integrity; build and lead a high-performing IT Quality organization with focus on AI, data integrity, and digital quality; establish standard practices across business lines and drive policy administration with leadership; develop inspection readiness approaches and manage the IT QMS; communicate IT Quality risks to stakeholders and respond to global inspection/audit observations.
Required Qualifications
- Bachelor's Degree
- 12+ years in a Quality Management role within the pharmaceutical industry
- Hands-on IT experience with FDA and international regulations
- Proven leadership in managing enterprise IT Quality systems, AI governance, and data integrity strategies
- Strong expertise in regulatory compliance and inspection readiness
- Experience with AI lifecycle management and emerging global regulatory frameworks
- Ability to lead cross-functional teams and influence enterprise-wide policy administration
- Exceptional skills in risk management and problem-solving within regulated environments
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