Senior Director, Expert Volunteer Operations

USP • Rockville, MD

21d

About The Position

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 USP’s 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 USP’s mission and the science vision. 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, 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 Director, Expert Volunteer Operations is a key role in the organization that manages Expert Volunteer Operations, a set of complex functions related to USP’s standards-setting processes, policies, approvals, communications, and improvements related to USP’s 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 1,000 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 USP’s 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 USP’s 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

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: Director