Head of IT Quality
About The Position
As the Head of IT Quality, you will spearhead the strategic direction for ensuring that Biogen's digital systems meet global quality and compliance standards, while facilitating efficient and cost-effective delivery. You will lead enterprise-level quality oversight of business-critical IT systems, including governance of GxP processes, system validation, and IT change control in line with regulatory expectations such as FDA guidance and EU standards. Your role will also establish oversight of quality policies related to Artificial Intelligence, ensuring compliance with emerging global frameworks and industry best practices. Moreover, you will be responsible for defining and driving the enterprise data integrity strategy, ensuring adherence to global regulatory expectations. This position is crucial to maintaining robust lifecycle management and inspection readiness of regulated records and data assets across Biogen, providing significant value in safeguarding quality and compliance within our IT infrastructure. This is a hybrid role that can be based either in Research Triangle Park, NC or Cambridge, MA.
Requirements
- Bachelor's Degree (MBA preferred).
- At least 12 years of experience in a Quality Management role within the pharmaceutical industry.
- Hands-on IT experience with a thorough understanding of 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.
Responsibilities
- Lead the strategic evolution of the Global IT Quality Management System, encompassing SDLC, change management, and risk management.
- Ensure validation of all IT systems for intended use, including AI-enabled systems, serving as a senior authority on policy interpretation.
- Provide quality oversight for business-critical systems, partnering with leadership on IT controls and data governance.
- Lead regulatory inspection readiness and serve as a subject matter expert as it relates to IT Quality, AI governance, and data integrity.
- Build and lead a high-performing IT Quality organization, focusing on capability development in AI, data integrity, and digital quality.
- Establish and implement standard practices, processes, and procedures across various business line functions.
- Drive activities and influence business leadership across the enterprise to ensure consistent policy administration.
- Develop and implement inspection readiness approaches and manage the QMS for IT.
- Communicate IT Quality risks to impacted stakeholders and respond to global inspection/audit observations.
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
