Job Description
Description
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 Digital Standards and Strategic Collaborations Manager will be the intrapreneurial, market-creating lead for USP’s efforts to drive industry adoption of digital standards in drug development and regulatory submissions. As a strategic leader within the newly formed Digital Standards business unit, this role will cultivate relationships with early adopters, facilitate pilot programs for the development and implementation of digital standards, and demonstrate the value of digital standards in regulatory contexts. Success will be measured by the number and quality of collaborative pilot projects between USP and industry, and the inclusion of digital standards into regulatory filings.
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. This critical position will spearhead those collaborations to shape a new paradigm of quality standards. You will help define the future of how pharmaceutical standards are delivered and used.
This role is remote, with an expected travel commitment of up to 50% for partner engagement, conferences, and pilot execution activities.
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 and Strategic Collaborations Manager has the following responsibilities:
+ Lead strategic engagement with pharmaceutical companies, regulators, and other relevant stakeholders to promote the adoption of USP’s digital standards in regulatory filings.
+ Develop and manage pilot programs with early adopters to validate the use of digital standards in real-world regulatory scenarios.
+ Collaborate cross-functionally with USP’s scientific, regulatory, and digital teams to align industry needs with solutions development.
+ Represent USP externally at industry forums, conferences, and regulatory roundtables to advocate for digital standards and share pilot outcomes.
+ Build and maintain strategic partnerships with key stakeholders across industry, regulatory agencies, contract organizations, and technology providers.
+ Monitor and report on adoption metrics, feedback from pilot participants, and market trends to inform strategy and product evolution.
This is both a strategic and operational role. The Senior Digital Standards and Strategic Collaborations Manager will design engagement strategies and personally lead early pilot execution to demonstrate the value of Digital Standards.
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 ten (10) years of experience leading strategic collaborations in pharmaceutical development, regulatory affairs, digital transformation, or related areas.
+ Prior experience contributing to regulatory submissions for pharmaceutical products, such as in a regulatory or CMC role.
+ Experience with and knowledge of domestic and international pharmaceutical industry regulations.
+ Experience with digital transformation in pharma (e.g., structured data, FAIR principles, digital QC/QA workflows, LIMS/ELN/CDS systems).
+ Familiarity with USP Standards and their use.
+ Excellent communication and interpersonal skills.
Additional Desired Preferences
+ Master’s degree in life sciences (chemistry, biology, pharmaceutical science, engineering, etc.) or business.
+ Familiarity with digitalization challenges and opportunities within the pharmaceutical industry.
+ Strong change leadership acumen and problem solving abilities.
+ Rigorous account development and management frameworks.
+ Demonstrable commitment to public health/patient safety/consumer protection.
+ Ability to engage with technical teams and translate between scientific, regulatory, and digital stakeholders.
+ Understanding of how Standards can be integrated into digital systems.
+ Entrepreneurial mindset.
+ Ability to influence without authority.
+ Comfortability with ambiguity and change.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Job Category Information Technology
Job Type Full-Time