Senior Manager, Verification Programs

Location: Rockville
Posted on: June 23, 2025

Job Description:

Description 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 1,300 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. 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 1-2x 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 high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making 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 high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven 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 USP's impact on public health. Upholds the program's 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: Bachelor's 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 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 $131,500.00 $170,500.00 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 specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor. Job Category Technical Programs Job Type Full-Time

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