Senior Director, Expert Volunteer Operations

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. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.

Brief Job Overview

This is a leadership role in Documentary Standards and Compendial Policy (DSCP) reporting to the Senior Vice President DSCP. The Senior Director Expert Volunteer Operations manages Expert Volunteer Operations a set of complex functions related to USPs standards-setting processes policies approvals communications and improvements. The Senior Director Expert Volunteer Operations is responsible for critical functions including Expert Volunteer Engagement Expert Committee Management and Standards of Conduct Program. This position plays a leadership role for management of expert committee and volunteer activities including transformation and continuous improvement of processes and policies. The incumbent also initiates supports and leads as appropriate related cross-divisional compendial activities related to USP COE Rules and Procedures. The incumbent interfaces with all parts and levels of the organization to fulfill their responsibilities including the Chief Science Office/Chair to the Counsel of Experts DSCP Leadership Team GSSD GEA and legal. The Senior Director Expert Volunteer Operations will utilize leadership influence operational experience regulatory knowledge and communication abilities to identify and drive change related to USPs mission and the science vision.

How will YOU create impact here at USP

As part of our mission to advance 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 operational excellence and risk-based decision-making to ensure the development and utilization on 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 Director Expert Volunteer Operations is a key role in the organization that manages Expert Volunteer Operations a set of complex functions related to USPs standards-setting processes policies approvals communications and improvements related to USPs expert volunteers. The Senior Director Expert Volunteer Operations oversees a couple of critical compendial functions: Expert Volunteer Engagement Expert Committee Management and Standards of Conduct Program. USP has over 1000 expert volunteers that are responsible for the standards scientific decisions and to ensure the integrity of the decisions the support of volunteers on process and policy is critical. Moreover the expert volunteers are volunteers so ensuring the experience is rewarding is essential including the ability to solve scientific issues network with peers and contribute clearly to USPs mission. Therefore this position plays a leadership role for management of expert committees and volunteer activities including transformation and continuous improvement of processes and policies to ensure the integrity of USPs standard setting process. The incumbent also initiates supports and leads as appropriate related cross-divisional compendial activities related to USP Council of Expert Rules and Procedures. The incumbent interfaces with all parts and levels of the organization to fulfill their responsibilities including the Chief Science Office/Chair to the Counsel of Experts DSCP Leadership Team GSSD GEA and legal.

The Senior Director Expert Volunteer Operations has the following 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 USPs expert volunteers and their activities.
• Oversees compendial stakeholder activities and their input to USP managing USPs interactions with compendial stakeholders (industry and others). Works across the organization to ensure consistency and balance across functions with stakeholder interactions and to evolve USPs understanding of stakeholders contributions and needs relative to USPs 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.

Who is USP 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:

• 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.

Additional Desired Preferences

• Masters or higher degree in health science or law.
• Understands USPs 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.

Supervisory Responsibilities

Yes this role manages approximately 14 individuals including a senior manager and director.

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 $202000.00 $262150.00 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 specificwritten agreement with USP.

Required Experience:

Exec