Senior Digital Standards and Industry Solutions Manager (REMOTE)

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 Senior Digital Standards and Industry Solutions Manager will be the intrapreneurial market-creating lead for USPs 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 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.

The Senior Digital Standards and Industry Solutions Manager has the following responsibilities:

• Lead strategic engagement with pharmaceutical companies regulators and other relevant stakeholders to promote the adoption of USPs 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 USPs 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 Industry Solutions Manage 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:

• Bachelors 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

• Masters 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$134100.00 $173900.00 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:

Manager