Director, Digital Standards Business Unit and Engagement
Scientific Framework, Enterprise Strategy & Governance
Define the scientific framework governing USP’s Digital Standards including scientific principles, structure, validation & traceability requirements, and lifecycle approach, in close collaboration with USP’s Science and Quality teams, and translate that framework into the enterprise strategy, operating model, and SOPs required to scale Digital Standards across USP operations.
Oversee Digital Standards lifecycle governance, ensuring scientific rigor on par with traditional USP Standards and consistent application of the scientific framework across product lines.
Ensure Digital Standards integrate with and support USP documentary standards and scientific development processes as the enterprise evolves.
Establish and continuously improve cross-functional governance (decision rights, portfolio prioritization, metrics, escalation) to balance speed, rigor, and compliance.
Provide executive-level updates, options, and recommendations to the Digital Standards steering committee and senior stakeholders.
Regulatory, Scientific & Industry Engagement
Own development and execution of the regulator, government, and industry engagement strategy required to appropriately shape the scientific framework and then to build alignment and cultivate champions for it across the pharmaceutical ecosystem.
Develop and oversee scientific and policy partnerships; collaborate with relevant departments and stakeholders, such as Legal, Science, and External Affairs to structure pilots and collaboration agreements with regulators, standards bodies, and pharmaceutical manufacturers.
Lead high-stakes external engagement with regulators, government agencies, standards bodies, scientific societies, and pharmaceutical manufacturers to align the field behind USP’s Digital Standards scientific framework and cultivate external champions.
Represent USP as a thought leader through conferences, publications, and industry forums; maintain relationships with key scientific, regulatory, and industry influencers.
Policy Frameworks & Implementation Enablement
Oversee internal and external policy frameworks for Digital Standards (structure, lifecycle, metadata, interoperability, implementation guidance) and ensure consistency across product lines.
Ensure policy is translated into practical implementation assets (schemas/specifications, guidance, training, playbooks) for industry and internal stakeholders.
Cook up cross-division alignment so Digital Standards policies fit within enterprise controls (quality systems, security, legal, and commercial governance).
Portfolio Oversight
Oversee portfolio-level strategic alignment, implementation plans, annual budgets, forecasts, and KPIs for Digital Standards Business Unit.
Translate market insights and performance analytics into portfolio choices.
Prioritize development for the portfolio of compendial Digital Standards and Digital Emerging Standards.
People Leadership, Talent Strategy & Culture
Build, lead, and develop a multi-disciplinary team spanning advocacy, strategic collaborations, scientific development, policy, and program management.
Provide functional oversight for the portfolio of digital products relating to Digital Standards to ensure alignment of product development with scientific, regulatory, and policy approaches.
Coach and develop leaders; set clear expectations and equitable performance management practices; foster an inclusive culture that supports growth and accountability.
Establish scalable operating rhythms (quarterly planning, portfolio reviews, KPI dashboards, stakeholder communications) that enable predictable delivery and learning.
Be a visible influencer for Digital Standards both internally and externally; facilitate information sharing and thought leadership through publications, presentations, discussions, and other fora.