Senior Digital Standards Policy and Implementation Manager (REMOTE)

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 

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, structured data submissions, and digital quality expectations.
• Draft regulatory comment letters, issue briefs, white papers, and policy analyses that articulate USP’s perspectives on digital standardization, data governance, and digital regulatory pathways.
• Represent USP in external policy‑focused working groups, standards bodies, and technical committees (e.g., ICH, ISO, PQ/CMC, Pistoia Alliance).
• Translate policy decisions into actionable implementation guidance, schemas, metadata requirements, and integration specifications for use by industry, technology vendors, and internal product teams.
• Collaborate with USP scientific, digital, and standards‑setting teams to ensure Digital Standards are developed in alignment with regulatory expectations and structured data principles.
• Provide subject‑matter expertise during Digital Standards pilot efforts, ensuring that pilots validate USP’s policy frameworks and deliver value to stakeholders.
• Monitor global regulatory and policy trends and provide insights and recommendations to internal leadership.
• Develop internal guidance documents, governance models, SOPs, and best practices that ensure consistency and compliance in the creation of Digital Standards.
• Support the development of thought‑leadership content on Digital Standards and digital regulatory transformation.

Success will be measured by the development and adoption of Digital Standards policy frameworks, regulatory engagement outcomes, and the quality and clarity of policy guidance produced to support internal teams, regulators, and industry stakeholders.

Who USP is 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:

• Bachelor’s degree in regulatory affairs, pharmaceutical sciences, data science, public policy, or a related field.
• Minimum of 10 years of experience in regulatory policy, regulatory affairs, data standards, structured submissions, or digital quality/CMC transformation.
• Experience contributing to regulatory submissions (IND, NDA, BLA, variations) or structured CMC data submissions.
• Experience developing or influencing regulatory policy frameworks, standards governance models, or structured data models (e.g., PQ/CMC, eCTD, XML/JSON schemas).
• Familiarity with global regulatory environments, including FDA, EMA, ICH, and other international regulatory bodies.
• Ability to translate complex scientific, regulatory, or technical concepts into clear policy positions or implementation guidance.
• Experience with digital transformation in pharmaceutical development, including FAIR principles, structured data approaches, or digital quality systems.
• Strong analytical and writing skills for policy documents, regulatory engagement materials, and technical implementation guidance.
• Experience engaging with standards organizations, policy forums, or regulatory working groups.
• Experience in pharmaceutical, scientific, healthcare, nonprofit, or regulated industries.

Additional Desired Preferences

• Master’s degree in life sciences (chemistry, biology, pharmaceutical science, engineering, etc.) or business.
• Experience drafting regulatory comments or participating in regulatory consultations.
• Hands‑on experience with structured data frameworks.
• Participation in formal standards‑setting groups.
• Entrepreneurial mindset prioritizing action and experimentation.
• Familiarity with existing digital ecosystems, including vendors, software packages, and emerging technologies and trends.
• Demonstrable commitment to public health/patient safety/consumer protection.
• Comfortability with ambiguity.

Supervisory Responsibilities

None, this is an individual contributor role.

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$134,100.00 – $173,900.00 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.

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.