Director, Digital Standards Business Unit and Engagement

U.S. Pharmacopeia

  • Rockville, MD
  • 2 days ago
  • $165,521–$213,700 Per Year

Highlights

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 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.

Numbers & Facts

LocationRockville, MD
Salary$165,521–$213,700 Per Year

Description

Director, Digital Standards Business Unit and Engagement

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.

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.

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:

  • Scientific Framework, Enterprise Strategy & Governance
  • Regulatory, Scientific & Industry Engagement
  • Policy Frameworks & Implementation Enablement
  • Portfolio Oversight
  • People Leadership, Talent Strategy & Culture

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

  • 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.
  • 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.
  • 5+ 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, or policy frameworks.
  • Demonstrated ability to convene and align regulators, government stakeholders, standards bodies, and pharmaceutical manufacturers around a shared scientific or policy framework.
  • Additional Desired Preferences

Supervisory Responsibilities

Yes, this is a supervisory role. The incumbent will oversee a team consisting of the following positions:

  • Direct Reports: 3+ across program management, stakeholder engagement, and policy development
  • Senior Digital Standards Scientific Collaboration Manager
  • Senior Digital Standards Policy & Implementation Manager
  • Program Manager – Digital Standards
  • Indirect / Second-Level 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 the 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. Compensation Base Salary Range: USD $165,521.00 – $213,700.00 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.

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