Director, Digital Standards Business Unit and Engagement

Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds—regardless of background—to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Brief Job Overview The Director leads USP’s Digital Standards Business Unit and is accountable for defining the scientific framework for USP’s Digital Standards and building the coalition of regulators, government stakeholders, and industry partners required to champion and adopt it. Success in Year 1 will include establishing the scientific principles, governance, structure, workflows, SOPs, and policy foundations that govern how USP develops and delivers Digital Standards, securing internal alignment and building engagement with regulators, standards bodies, and pharmaceutical manufacturers to align the field behind that framework and its implementation. This individual will represent USP in high-stakes external scientific and regulatory forums and serve as a visible thought leader on the future of digital pharmacopeial quality standards. The Director works highly cross-functionally with USP’s Science, Quality, Lab Operations, digital products, IT, Commercial, and other teams to ensure Digital Standards are deeply anchored in USP’s compendial and commercial processes. The Director will also have functional oversight of the portfolio of digital standards products, including USP-ID and MethodConnect, ensuring product direction aligns to the scientific framework. Commercial scale-up and market adoption are priorities in subsequent years that will follow framework and stakeholder alignment. This role requires scientific rigor and skills in both internal change management and external stakeholder alignment within the scientific realm. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. You will strengthen trust and usability of standards in digital workflows - helping scientists, regulators, and industry teams adopt rigorous, structured, and interoperable quality standards faster and with less friction. You will also ensure USP’s Digital Standards and related digital offerings are delivered with appropriate rigor, validation strategy, and secure-by-design practices. The Director, Digital Standards Business Unit and Engagement, has the following responsibilities: 1) 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. 2) 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. 3) 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. • Coordinate cross-division alignment so Digital Standards policies fit within enterprise controls (quality systems, security, legal, and commercial governance). 4) 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. 5) 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. • Es