Senior Digital Standards Policy and Implementation Manager; REMOTE

Overview

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

USP is seeking a Senior Digital Standards Policy and Implementation Manager to lead the development of internal and external policy frameworks that support the creation, governance, and regulatory adoption of Digital Standards. This role bridges regulatory policy, digital standardization, and practical implementation, ensuring that USP’s Digital Standards align with global regulatory expectations, structured data initiatives, and emerging digital quality workflows. The ideal candidate has expertise in regulatory science, data standards, and digital transformation, and is able to translate policy into actionable implementation guidance.

This role is critical in shaping how regulators, industry, and technology partners understand and apply Digital Standards in analytical development, quality control, and regulatory submissions.

As pharmaceutical development and manufacturing continues its digitalization journey, USP is seeking to take an active, collaborative role in helping advance digitalization of analytical development and quality control workflows through the delivery of chemical reference and analytical method standards directly into digital environments. You will help define how Digital Standards are governed, validated, implemented, and communicated across the pharmaceutical ecosystem

This role is remote, with an expected travel commitment of up to 20% for policy workshops, conferences, and external engagement

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.

The Senior Digital Standards Policy and Implementation Manager has the following responsibilities:

• Develop internal policy frameworks for the creation, governance, structure, and lifecycle management of USP Digital Standards.
• Lead the development of USP’s external policy positions for FDA, EMA, ICH, WHO, and other regulatory bodies related to Digital Standards,…