Director, Digital Standards Business Unit and Engagement

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds 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 1300 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 mindsregardless of backgroundto 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 Director leads USPs Digital Standards Business Unit and is accountable for defining the scientific framework for USPs 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 USPs Science Quality Lab Operations digital products IT Commercial and other teams to ensure Digital Standards are deeply anchored in USPs 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.

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 USPs 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 USPs 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:

1) Scientific Framework Enterprise Strategy & Governance

• Define the scientific framework governing USPs Digital Standards including scientific principles structure validation & traceability requirements and lifecycle approach in close collaboration with USPs Science and Quality teams and translate that framework into the enterprise strategy operating model and SOPs required to scale Digital Standards across USP operations.
• Oversee Digital Standards lifecycle governance ensuring scientific rigor on par with traditional USP Standards and consistent application of the scientific framework across product lines.
• Ensure Digital Standards integrate with and support USP documentary standards and scientific development processes as the enterprise evolves.
• Establish and continuously 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.

2) Regulatory Scientific & Industry Engagement

• Own development and execution of the regulator government and industry engagement strategy required to appropriately shape the scientific framework and then to build alignment and cultivate champions for it across the pharmaceutical ecosystem.
• Develop and oversee scientific and policy partnerships; collaborate with relevant departments and stakeholders such as Legal Science and External Affairs to structure pilots and collaboration agreements with regulators standards bodies and pharmaceutical manufacturers.
• Lead high-stakes external engagement with regulators government agencies standards bodies scientific societies and pharmaceutical manufacturers to align the field behind USPs Digital Standards scientific framework and cultivate external champions.
• Represent USP as a thought leader through conferences publications and industry forums; maintain relationships with key scientific regulatory and industry influencers.

3) 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.
• Ensure policy is translated 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).

4) Portfolio Oversight

• Oversee portfolio-level strategic alignment implementation plans annual budgets forecasts and KPIs for Digital Standards Business Unit.
• Translate market insights and performance analytics into portfolio choices.
• Prioritize development for the portfolio of compendial Digital Standards and Digital Emerging Standards.

5) 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 relating to Digital Standards to ensure alignment of product development 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) that enable predictable delivery and learning.
• Be a visible influencer for Digital Standards both internally and externally; facilitate information sharing and thought leadership through publications presentations discussions and other fora.

Who is USP Looking For

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

• Experience operating in or adjacent to regulated digital environments including validation strategy planning data integrity and quality systems.
• Demonstrated change leadership experience including implementing digital transformation at an organization-wide level.
• Familiarity with structured data standards and interoperability approaches (schemas metadata frameworks).
• Experience with scientific content workflows and analytical methods and/or digital method lifecycle frameworks.
• Experience with analytical chemistry technologies including NMR FTIR MassSpec HPLC and others.
• Experience in the development of public standards.
• Experience with 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

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 $165521.00 $213700.00 annually.

Target Annual Bonus: % Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other job-related reasons.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Director