Senior Manager, Verification Programs

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 highquality 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 meritbased 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.

Brief Job Overview

This is a direct supervisory position in the Verification team of USPs Global Laboratory and Technical
Operations division. The incumbent is primarily responsible for providing technical and operational
management for the verification programs. Responsibilities include managing and conducting activities
related to current Good Manufacturing Practice (cGMP) site audits quality control and manufacturing
(QCM) product documentation reviews and test design. In addition the incumbent helps develop and
implement new tools procedures and techniques for the verification team to meet USPs objectives and
to support continued growth.

This is a mostly remote role that requires mandatory 12x a month visits to the Rockville MD headquarters. Employees must reside in one of the following states: MD DC VA WV PA IL MI MN KS FL NC OR CA.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role
in increasing global access to highquality medicines through public standards and related programs.
USP prioritizes scientific integrity regulatory excellence and evidencebased decisionmaking to ensure
health systems worldwide can rely on strong tested and 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 highperforming
inclusive teams. This includes training in equitable management practices and tools to promote engaged
collaborative and resultsdriven work environments.

The Senior Manager Verification Programs has the following responsibilities:

Leads the verification operational team. Provides technical expertise and guidance to team
members.
Demonstrates a deep understanding of USPs impact on public health. Upholds the programs
integrity and impartiality.
Develops and mentors staff holds employees accountable for results.
Collaborates closely with other departments (e.g. laboratories business team) to ensure timely
delivery of results and efficient issue resolution.
Engages with manufacturers to ensure necessary corrective actions are implemented and
provides status reports to guarantee timely service delivery.
Monitors industry landscape and acts as the technical expert for outreach including delivering
presentations authoring white papers and articles.
Leads implementation efforts for continuous improvement. Monitors trends and works to
improve daily operations.
Performs other duties as 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:

Bachelors degree in chemistry or a related scientific field and 15 years of relevant experience or
masters degree in chemistry or a related scientific field and 12 years of relevant experience or
Ph.D. in science and 10 years of relevant experience.
Minimum of eight (8) years of relevant experience working in current Good Manufacturing
Practice (cGMP) facilities engaged in the manufacturer and/or quality control of dietary
supplements and/or pharmaceuticals.
Knowledge of and experience with GMP audits using 21 CFR parts 111 and 117 is required.
Working knowledge and experience with compendial standards analytical methodologies
analytical method development and validation.
Minimum of 4 years of people management experience.

Additional Desired Preferences

Extensive knowledge of FDA regulations pertaining to cGMP requirements and proficiency
with regulation and guideline interpretation audit procedures proper documentation and
quality assurance.
Experience with ISO accreditation including ISO 17020 and ISO 17065.
Industry experience in the manufacture of dietary supplements and/or pharmaceuticals with
a variety of dosage forms.
Working experience conducting and/or hosting cGMP audits.
Certification from the American Society for Quality (ASQ) as a Certified Quality Auditor
(CQA) and/or from the Regulatory Affairs Professional Society (RAPS) as a Regulatory
Affairs Certified (RAC) professional.
Working knowledge of the International Conference on Harmonization (ICH) quality
guidelines and multidisciplinary guideline on the Common Technical Document (CTD) for
pharmaceuticals and/or regulatory Chemistry Manufacturing Controls (CMC) submission
experience.
Detail oriented and good organizational and planning skills.
Excellent technical writing and oral communication skills required. Must be able to
communicate effectively with diplomacy and enthusiasm.
Able to deal with multiple changing priorities and work with minimal supervision.

Supervisory Responsibilities

Yes. This position will have at minimum five direct and two functional reports consisting of varying
levels of Scientists and GMP Auditors.

Benefits

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

Compensation

Base Salary Range: USD $131500.00 $170500.00 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 jobrelated 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 specific written agreement with USP.

Required Experience:

Senior Manager