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US Pharmacopeia · 1 day ago

Senior Director, Expert Volunteer Operations

Rockville, MD

Full-time

Onsite

Director/Executive

$202K/yr - $262K/yr

11+ years exp

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization committed to developing quality standards for medicines and dietary supplements. The Senior Director, Expert Volunteer Operations plays a key leadership role in managing Expert Volunteer Operations and overseeing critical functions related to USP’s standards-setting processes and policies.

MedicalNon ProfitPharmaceuticalPublishing

H1B Sponsor Likely

Responsibilities

Responsible for leading critical areas including the expert volunteer processes, standards of conduct, and expert committee managers. The position is responsible for enhancing the experience of our volunteers while also managing the process to ensure the integrity of the USP standard setting process. It requires a solution-oriented individual that can navigate rules while also being agile to incorporate innovative solutions to ensure quality, efficiency, and transparency

Provide leadership to functions that support the expert volunteers, global science leadership, the Legal Department, and others to support ongoing standard-setting processes, policies, and associated activities, and to facilitate implementation of new and improved processes related to our exert volunteers

Represent the Science Division in cross-functional initiatives to provide consultation and insights into USP’s expert volunteers and their activities

Oversees compendial stakeholder activities and their input to USP, managing USP’s interactions with compendial stakeholders (industry and others). Works across the organization to ensure consistency and balance across functions with stakeholder interactions and to evolve USP’s understanding of stakeholders’ contributions and needs relative to USP’s mission and strategies

Responsible for compendial engagement with FDA on behalf of USP and works with GEA and others to manage interactions and ensure a continued strong relationship with FDA

Performs the responsibilities of executive secretariat to the Council of Experts and manages all activities of the COE

Maintains and updates applicable SOPs and other process documents and templates

Performs all other job duties including special projects as requested or assigned

Qualification

Expert Committee ManagementRegulatory KnowledgeStakeholder EngagementPeople LeadershipConflict of Interest ManagementProcess ImprovementCommunication SkillsCritical ThinkingProblem-Solving SkillsMentoring Skills

Required

Minimum of 11-13 years of experience in organizations in government/regulatory, or related field

Minimum of 3 years people leadership experience

Demonstrated ability to establish strong working relationships and influence culture with all levels of people in an organization

Ability to perform and supervise in a matrix environment

Experience managing conflict of interest or ensuring the integrity of processes and systems

Understanding of the sciences and/or the regulatory aspects of pharmaceuticals, biologics, food, dietary supplements, or healthcare Ability to build a team through mentoring, training, and supervisory skills

Possesses extensive knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and guidance

Preferred

Master's or higher degree in health, science, or law

Understands USP's impact on compendial stakeholders and how stakeholders may work with USP

Ability to absorb new complex material quickly and frequently

Demonstrated ability to successfully manage multiple concurrent projects in a timely manner

Excellent facilitation, communication, and presentation skills

Excellent critical thinking and problem-solving skills

Able to operate independently where appropriate yet understand when to escalate issues and how to establish effective working relationships in a team setting

Benefits

Company-paid time off

Comprehensive healthcare options

Retirement savings

Company

US Pharmacopeia

Glassdoor3.6

US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820.

Founded in 1820

Rockville, Maryland, USA

1001-5000 employees

http://www.usp.org/

H1B Sponsorship

US Pharmacopeia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (9)

2024 (2)

2021 (2)

2020 (2)