Senior Digital Standards and Industry Solutions Manager (REMOTE)

USP • Rockville, MD

6d • Remote

About The Position

The Senior Digital Standards and Industry Solutions 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level