Senior Director, External Affairs

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 Senior Director, External Affairs – Biologics will lead USP’s efforts to shape regulatory policy and engage with and influence key stakeholders to advance USP standards for biologics products. This role will partner closely with the Biologics Division and colleagues in GEA and RPS and serve as the lead in a coordinated and comprehensive regulator/policy maker/stakeholder group strategy to advance USP’s current and future portfolio of solutions to advance development and supply of biologics medicines. Shaping the regulatory environment in the US with direct and indirect engagement with the US FDA, along with building stakeholder support will be central to the role. Moreover, while the US is primary, advancing USP goals in biologics in other regions will also be a priority.  In the course of engaging with policy makers, influencers, and stakeholders, the Senior Director will also gather, synthesize, and communicate insights among USP leaders which can be integrated into broader planning.

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 Director, External Affairs – Biologics has the following responsibilities:

• Comprehensive Biologics Engagement and Influence Plan: Lead the development of a comprehensive external affairs engagement and influence plan to advance the development and utilization of USP’s current and future biologics standards portfolio, working across Global External Affairs in close collaboration with the Biologics Division.
• Stakeholder Management: Collaborate with colleagues in Global External Affairs and the Biologics Divisions identify, map, and nurture relationships with leading influencers and decision makers on supply chain resilience topics relevant to USP’s supply chain portfolio. This will include prioritized and deeper engagement with identified organizations.
• Thought Leadership: Partner with colleagues in Biologics and Global Communications to develop and ensure execution of a thought leadership program that engages influencers in dialogue about the challenges and USP solutions to expanding the supply of biologics medicines. Focus areas will including standards and related regulatory matters in the US, and opportunities in advanced biologics medicines. Excellent written and other communications that clearly communicates the contributions of USP standards to addressing key problems faced by regulators and industry will be essential.
• Regulator Engagement and Influence<