Executive Director, Digital Governance and Portfolio Management

This role is considered a senior leader responsible for establishing and operating governance, regulatory compliance, and portfolio management practices that support the company’s consolidated IT and digital organization. Reporting to the Chief Information Officer, you partner closely with business partner teams and executives across the enterprise, the IT Leadership team (Infrastructure, AI/Data and Analytics, and Applications teams) and the Enterprise Project Management team to ensure that IT decisions, investments, and controls are consistent, transparent, and aligned to enterprise priorities.

You are accountable for the enterprise IT governance framework, the IT project and product portfolio, and the compliance posture of computerized systems supporting FDA regulated operations, including systems such as ERP, lab applications, and other GxP-relevant platforms. You establish policies, risk management practices, and audit readiness capabilities that allow the digital organization to operate securely and in compliance with applicable FDA and other regulatory requirements.

You partner with Quality, Regulatory Affairs, Security, Legal, and Finance to ensure that governance, compliance, and portfolio decisions reflect both regulatory obligations and business priorities, and you represent IT Governance, Compliance & Portfolio in executive planning and strategic technology discussions.

IT Governance & Policy Leadership

• Establish and lead NYBCe's enterprise IT governance framework, including decision rights, policy standards, and operating cadences across the consolidated digital organization.
• Define and maintain IT policies, standards, and procedures spanning Infrastructure, AI/Data and Analytics, and Business Analysis/Enterprise Applications functions.
• Lead governance forums (e.g., architecture review, change advisory, demand intake, project prioritization) to ensure consistent decision-making across teams.
• Partner with executive leadership and manage the Technology Governance Council to align IT governance practices with enterprise risk appetite and organizational objectives.
• Own the IT policy lifecycle, ensuring policies remain current, communicated, and adopted across the organization.

Regulatory Compliance & Quality Systems

• Ensure IT and computerized systems practices comply with applicable FDA and other industry regulations, including 21 CFR Parts 210/211, the 600-series biologics regulations, and other relevant industry regulatory requirement for establishment computer systems.
• Own the GxP computerized systems inventory, risk classification methodology, and qualification/validation program, incorporating current Computer Software Assurance (CSA) guidance.
• Partner with Quality Assurance and Regulatory Affairs to maintain SOPs governing system validation, change control, and periodic review.
• Serve as the primary IT point of contact for FDA inspections, internal audits, and regulatory inquiries related to computerized systems.
• Maintain awareness of evolving FDA, USP, biologics and other industry-related requirements and translate them into practical IT governance controls.
• Take responsibility for all departmental training at the enterprise level.

IT Portfolio & Investment Management

• Own the enterprise IT portfolio management process, including demand intake, prioritization, capacity planning, and investment tracking across all digital teams.
• Establish a standard project and product intake framework that balances Infrastructure, Data/AI, and Business Applications priorities.
• Provide executive-level portfolio reporting, including status, risk, spend, and value realization, to senior leadership.
• Partner with Finance on IT budget planning, capital/OPEX forecasting, and business case…