U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) (Senior) Director, Documentary Standards Operational Excellence in Rockville, Maryland


Who is USP?

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 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 the Compendial Operations (CO) Department in the Operational Excellence Function reporting to the Vice President. The Senior Director, Operational Excellence oversees several critical compendial functions related to USP’s standards-setting processes, policies, approvals, communications, and improvements, as well as operational programs and standards-setting portfolio work related to USP’s mission and strategy. The Senior Director, Operational Excellence will utilize leadership, influence, operations experience, and communication abilities to identify and drive change through continuous improvement.

How will YOU create impact here at USP?

  • Provide leadership to functions that collaborate with Global Science and Standards Division staff and leadership (the Legal Department, External Affairs, and others) to support ongoing standard[1]setting processes, policies, and associated activities.

  • Provide holistic management of capacity that includes processes as well as technology and provide regular management reports which include current usage of resources, trends, and forecast. Establish and implement a strategy for capacity management across the standard setting process.

  • Oversee the activities of the standard-setting process to ensure end-to-end quality and efficiency. Evaluate, design, measure, and monitor the business process management system for documentary standards. Coordinate business process improvement strategies with internal stakeholders.

  • Apply experience in systematic Operational Excellence initiatives (Organizational Transformation and Program Management) with a primary focus on optimization and excellence in execution which includes clearly defining the project scope of work, the approach for planning and execution, developing the schedules to meet milestones, defining resource requirements, KPIs, progress and benefits tracking, and communications/reporting.

  • Proactively collaborate with Vice President of Compendial Operations and Leaders to identify and commit resources with proven skillsets/experience to engage on the projects, deliver above and beyond the expected value delivery and maintain high levels of resource utilization.

  • Partner with other Senior Leaders in the consistent application of policies and practices department-wide to assure compliance with prescribed practices that effectively use metrics and data analytics to manage workload assignments and prioritize resources.

  • Oversee staff and continuously search for, recommend, and implement process and policy improvements and best practices; takes a leadership role in fostering a quality improvement mindset and culture.

  • Operate transparently including keeping leadership and internal customers advised on progress, status, and potential/emerging/active issues and actively manages risk.

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:


  • Bachelor’s with 8 years of experience, Masters with 5 years or Ph.D. with 3 years in organizations in science, health care, government/regulatory, or related leading operational or business management function.

  • Exceptional leadership, collaboration, and communication skills. Advanced analytical and problem-solving skills.

Senior Director:

  • Bachelor’s with 11 years of experience, Masters with 8 years or Ph.D. with 6 years in organizations in science, health care, government/regulatory, or related leading operational or business management function.

  • Exceptional leadership, collaboration, and communication skills. Advanced analytical and problem-solving skills.

We especially welcome applications from those who hold historically marginalized and/or underrepresented identities. This job description provides a portrait of an ideal candidate. Candidates who possess many, though perhaps not all, qualifications are encouraged to apply.

Additional Desired Preferences

  • Understanding of the sciences and/or the regulatory aspects of pharmaceuticals, biologics, food, dietary supplements, or healthcare.

  • 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 developing and implementing best practices working to attain organization.

  • Knowledge in capacity management, case management, and business process management systems. Ability to absorb new complex material quickly and frequently.

  • Able to distill large amounts of information into executable strategies.

  • Able to adapt landscapes, strategies, and workplans based on organizational needs and constraints.

  • Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.

  • Able to establish and cultivate relationships with individuals of varying backgrounds, cultures, and learning styles.

  • Excellent facilitation, communication, and presentation skills.

  • Excellent critical thinking and problem-solving skills.

  • Ability to build a team through mentoring, training, and supervisory skills.

Supervisory Responsibilities

5-10 staff members to include Program Managers, Project Coordinators and supporting staff


USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved.

Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Chemistry & Scientific Standards

Job Type Full-Time