Director, Digital Standards Strategy and Regulatory Science

Description

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.

USP is seeking a scientific and regulatory leader for its Digital Standards Business Unit who is accountable for defining the scientific framework for USP’s digital pharmacopeial 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, policy foundations and workflows 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.

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. Internally, the Director will work highly cross-functionally with USP’s Science, Quality, Lab Operations, IT, Commercial, and other teams to ensure Digital Standards are embedded in USP’s compendial and commercial processes. The Director will also have functional oversight of the portfolio of Digital Standards products, including USP
- Method Connect, ensuring product direction aligns to the scientific framework. Scale-up and market adoption are priorities in subsequent years that will follow framework and stakeholder alignment.

This role requires skills in both internal change management and external stakeholder alignment within the scientific realm.

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.

• Define the scientific framework governing USP’s Digital Standards including scientific principles, structure, rigor requirements, and lifecycle approach, in close collaboration with USP’s Science and Quality teams, and translate that framework into…