The U.S. Pharmacopeial Convention (USP) Manager, New Use Program and Compliance in Rockville, Maryland
Manager, New Use Program and Compliance
This is a hands-on supervisory position in the Reference Standards Technical Operations (RSTO) department within Global Laboratory Operations (GLO). The incumbent in this role will lead staff to design and implement quality processes, resolve compliance related issues and perform quality and technical review of documents. The incumbent will also lead a team to ensure the suitability of Reference Standards used in the new and revised monographs (New Use program) to support USP’s Mission and core business.
Roles and Responsibilities
Performs reviews of documents to ensure a high level of quality within the department.
Proactively involved in working with the Reference Standards Evaluation and Quality Assurance departments to resolve compliance related issues.
Manages all aspects of the New Use Program and leads implementation efforts for continuous improvements.
Develops and reviews SOP’s, Operation Manuals and training documents.
Manages departmental quality measurements. Monitors trends and works to improve quality in daily operations.
Bachelor’s degree in Chemistry or a related field and 9 years of relevant experience or a Master’s degree in Chemistry or a related scientific field and 7 years of relevant experience or a Ph.D. in science and 5 years of relevant experience.
Minimum of 2 years of direct supervisory experience and/or team lead.
Minimum of 4 years of Quality Assurance experience.
Skills to develop the knowledge, abilities and contributions of staff.
Excellent technical writing and oral communication skills required. Must be able to communicate effectively with diplomacy and enthusiasm across the organization.
Knowledge of issues related to the evaluation of purity and content of reference standards.
Ability to handle multiple priorities in a fast-paced environment.
The ability to influence without direct authority.
Yes, this position has a minimum of three direct reports:
Systems and Compliance Manager
USP offers an impressive benefits package , including:
Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
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.
Rockville, Maryland, United States
Job Category Scientific