Executive Director, Digital Governance and Portfolio Management

Senior IT Governance LeaderThis 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 LeadershipEstablish 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 SystemsEnsure 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 ManagementOwn 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 development for major initiatives.Drive adoption of consistent project delivery and PMO practices across the consolidated digital organization.Ensure projects have defined ROI and metrics of success prior to approach and launch.Risk Management & Audit ReadinessSupport enterprise IT risk assessment practices, including identification, scoring, remediation tracking, and reporting.Ensure IT readiness for internal, external, and regulatory audits, including timely evidence gathering and issue remediation.Support company-wide business continuity and disaster recovery planning for critical systems, including ERP, MES, lab applications, and helpdesk operations.Track and report on remediation of audit findings and regulatory observations related to IT and computerized systems. Spearhead remediation planning and action.Vendor & Contract GovernanceEstablish governance practices for evaluating, onboarding, and managing key technology vendors and software contracts.Support vendor risk assessments, including data security, business continuity, and regulatory considerations.Manage company-wide technology contract and billing lifecycles.Cross-Functional & Strategic LeadershipSupport the CIO by defining and taking on "Office of the CIO" duties.Define and report monthly on key performance metrics for the enterprise technology organization as a whole.Partner with the leaders of Infrastructure, AI/Data and Analytics, and Business Analysis/Enterprise Applications to ensure governance practices support a unified digital organization.Represent IT Governance, Compliance, and Portfolio functions in enterprise strategy discussions and other forums.Champion a culture of accountability, transparency, and continuous improvement across the digital organization.Event ManagementManage the functional lead and their team of direct reports in ensuring successful remote events.Working with peers within the IT organization, serve as the technical owner for the hardware and software platforms supporting removing events.Ensure support and staffing coverage at events by establishing a planning process with the events team business partners.Team Leadership & DevelopmentBuild, lead, and develop a team responsible for IT governance, compliance, project management, and portfolio management functions.Establish clear roles, workflows, and career development paths for governance, relationship management and PMO staff.Manage performance, coaching, and professional development for direct reports.Foster collaboration between the new function and delivery teams across the consolidated digital organization.QualificationsEducation:Bachelor's degree in Information Technology, Computer Science, or a related STEM field.Experience:12 -15+ years of progressive IT experience, including significant experience in IT governance, compliance, risk management, business process engineering, and/or portfolio/PMO leadership.7+ years of experience in a healthcare, life sciences, pharmaceutical, or other FDA-regulated environment.Demonstrated experience with FDA computerized systems requirements, including validation/qualification practices, Data Integrity, and Computer Software Assurance (CSA) principles.Experience establishing or leading enterprise IT governance frameworks, policies, and standards.Experience managing IT portfolios, including demand intake, prioritization, and investment reporting.Experience leading audit readiness activities and managing regulatory inspection support for IT/computerized systems.Strong track record partnering with Infrastructure, Data/Analytics, and Applications teams to drive consistent governance practices.Demonstrated ability to communicate governance, risk, and compliance matters to executive leadership.Knowledge:IT governance frameworks, operating models, and policy management.FDA regulatory requirements applicable to computerized systems in regulated healthcare or biologics manufacturing.IT portfolio management, project/product intake, and PMO practices.Enterprise risk management, audit readiness, and controls frameworks.Vendor and contract management practices, including software licensing and framework agreements.Business continuity and disaster recovery planning principles.Skills:Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.Establish and lead governance frameworks across a multi-disciplinary technology organization.Translate regulatory requirements into practical, actionable IT controls and processes.Manage complex portfolios spanning infrastructure, data/AI, and business applications.Communicate effectively with executives, regulators, auditors, and technical staff.Balance compliance obligations with delivery speed and business needs.Abilities:Build and scale governance, compliance, and portfolio functions supporting enterprise growth.Influence and collaborate effectively across organizational boundaries and leadership teams.Make informed decisions under ambiguity, regulatory scrutiny, and competing priorities.Develop future leaders through mentorship and coaching.Drive accountability and continuous improvement across governance and compliance practices.Any combination of education