Director, Digital Standards Strategy and Regulatory Science

About the role

The U.S. Pharmacopeial Convention (USP) is seeking a scientific and regulatory leader for its Digital Standards Business Unit. This individual will define the scientific framework for USP’s digital pharmacopeial standards and build a coalition of regulators, government stakeholders, and industry partners to champion and adopt it. Success in Year 1 includes establishing scientific principles, policy foundations, and workflows, securing internal alignment, and engaging with key stakeholders to align the field behind the framework.

This role requires representing USP in high-stakes external scientific and regulatory forums and serving as a thought leader on the future of digital pharmacopeial quality standards. Internally, the Director will collaborate with USP’s Science, Quality, Lab Operations, IT, Commercial, and other teams to embed Digital Standards into USP’s compendial and commercial processes. The Director will also oversee the portfolio of Digital Standards products, including USP-ID and MethodConnect, ensuring alignment with the scientific framework.

Responsibilities

• Scientific Framework, Enterprise Strategy & Governance
  • Define the scientific framework governing USP’s Digital Standards, including scientific principles, structure, rigor requirements, and lifecycle approach, in collaboration with USP’s Science and Quality teams.
  • Translate the framework into the enterprise strategy and operating model required to scale Digital Standards across USP divisions.
  • Oversee Digital Standards lifecycle governance, ensuring scientific rigor on par with traditional USP Standards and consistent application of the framework across product lines.
  • Ensure Digital Standards integrate with and support USP documentary standards and scientific development processes.
  • Establish and 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 the development and execution of the engagement strategy for regulators, government, and industry to build alignment and cultivate champions for the scientific framework.
  • Develop and oversee scientific and policy partnerships; collaborate with Legal and other stakeholders to structure pilots and agreements with regulators, standards bodies, and 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 framework.
  • 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.
  • Translate policy 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).
• Portfolio Oversight
  • Oversee portfolio-level strategic alignment, implementation plans, annual budgets, forecasts, and KPIs for the Digital Standards Business Unit.
  • Translate market insights and performance analytics into portfolio choices.
  • Prioritize development of the 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 to ensure alignment 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) for predictable delivery and learning.
  • Be a visible influencer for Digital Standards both internally and externally; facilitate information sharing and thought leadership through publications, presentations, and discussions.

Requirements

• 10+ years of progressive experience in pharmaceutical sciences, analytical chemistry, regulatory science, or a closely related scientific discipline, with demonstrated scientific credibility recognized by peers in industry, regulators, or standards bodies.
• 7+ years of people management experience, including building multi-disciplinary teams across advocacy, scientific, policy, and program functions.
• Proven ability to implement changes across a matrixed organization, including influencing senior stakeholders and shaping governance, operating models, workflows, and policy frameworks.
• Demonstrated ability to convene and align regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a shared scientific or policy framework.
• Advanced degree (PhD, PharmD, MS, or equivalent) in a scientific, pharmaceutical, or analytical discipline, or a comparable track record of peer-reviewed publications, contributions to public standards development, or recognized leadership in scientific or regulatory working groups.

Preferred Qualifications

• Experience within a regulatory or standard-setting body, such as FDA, EMA, or ICH.
• Understanding of the pharmacopeial standard-setting process and its relevance in pharmaceutical product development and quality control.
• Experience with scientific content workflows, analytical methods, and/or digital method lifecycle frameworks.
• Experience with analytical chemistry technologies, including NMR, FTIR, MassSpec, HPLC, and others.
• Experience establishing strategic collaborations, including drafting agreements with pharmaceutical or other life science organizations.
• Strong strategic thinking, negotiation, communication, and stakeholder engagement skills; comfort operating with ambiguity in a fast-evolving domain.

Supervisory Responsibilities

• Direct Reports: 2+ across program management, stakeholder engagement, and policy development.
  • Senior Digital Standards Policy & Implementation Manager
  • Program Manager – Digital Standards
• Functional Reports:
  • Director Digital Reference Standards Development
  • Product Manager – USP-ID
  • Senior Product Manager – MethodConnect
  • Marketing Specialist – Digital Standards
  • 1-3 Scientists – qNMR application development

Benefits

USP provides benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Pay

Base Salary Range: USD $167,343.00 – $238,464.00 annually. Target Annual Bonus: Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons.

Schedule

Full-Time