Head of IT Quality

About This Role:

 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.

What You’ll Do:

• 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.

Who You Are: 

You are a forward-thinking leader with a passion for quality and compliance in the digital space. Your ability to communicate complex IT Quality risks and solutions inspires confidence and clarity among stakeholders. You thrive in collaborative environments, establishing and implementing standard practices that enhance organizational effectiveness. With a strategic mindset, you drive innovation and excellence, ensuring Biogen's IT systems are aligned with global regulatory expectations and industry best practices.

Required Skills:

• 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.

 

Job Level: Management

Additional Information

The base compensation range for this role is: $178,000.00-$245,000.00

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-y