Manager, Verification Services (940-679)
This is a hands-on supervisory position that supports the important work of USP’s verification programs. The incumbent is primarily responsible for providing technical and operational project management for the verification programs in the area of dietary supplements. Responsibilities include managing and conducting activities related to current Good Manufacturing Practice (cGMP) site audits; quality control and manufacturing (QCM) product documentation reviews; and product sample testing for conformance to applicable compendial specifications for the USP verification program (VER) department. The incumbent serves as the primary contact for a number of participating companies and manages verification projects for the companies, working closely with participating companies and with fellow staff throughout the verification process to ensure timely completion of work. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent helps develop and implement new tools, procedures and techniques for the verification department to meet USP’s objectives and to support continued growth of verification services as a center of excellence within USP’s fast-paced, rapidly changing organization.
Roles and Responsibilities:
- Conducts thorough technical review and evaluation of quality control and manufacturing (QCM) product documentation and other information received from dietary supplement manufacturers (i.e., verification program participants) to ensure compliance with USP verification program requirements and prepares reports on observations made during the review.
- Enters into correspondence with manufacturers to ensure that acceptable corrective actions are taken where needed and prepares status report for the VER department.
- Prepares test protocols for product samples undergoing testing for compliance to specifications, and effectively assists chemists who conduct laboratory work to ensure testing is carried out in accordance with the project plan, and that any out-of-specification results are properly investigated.
- Prepares and/or evaluates cGMP site audits/reports, QCM product documentation/reports, and product test data/results/reports, regarding facilities and products undergoing verification.
- Ensures manufacturer compliance with verification program procedures and requirements in the preparation of summary reports and approval letters for final disposition of products undergoing verification.
- Monitors the working relationship and work schedule with verification program staff, other USP departments, contract auditors, and external testing laboratories, on matters relating to the verification programs.
- Provides supervision to direct reports, and contract auditors as needed, and works collaboratively with verification staff based at USP Rockville and other USP sites (India and China) to ensure effective management and timely completion of verification projects.
- Conducts audits of verification program participant’s national and/or international sites for cGMP compliance and with USP verification programs requirements, as needed, and prepares audit reports summarizing the results of the site audits and makes observations regarding site compliance with cGMP requirements.
- Develops and/or revises the standard operating procedures (SOPs) and verification program manuals for participants, for continual improvement of the program requirements and operation, in collaboration with the verification staff and with other USP department (e.g., QA and Legal) staff.
- Establishes and maintains procedures, processes, and requirements for the USP verification programs, and adheres to procedures, processes, and requirements of the USP verification programs.
- Participates in internal audits of the verification department and works with verification staff to respond and initiate corrective action for audit findings.
- Participates in USP Pharmacopeial Education (PE) courses, when needed.
- Performs required training.
- Completes requisition orders and expense reports for travel and materials related to VER activities.
- Performs other duties as assigned by Senior Director, Verification Programs, or designee.
- Ph.D. or M.Sc. degree (or equivalent combination of education and experience) in analytical chemistry, biochemistry or other related fields.
- Minimum of five (5) 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.
- Working knowledge and experience with compendial standards, analytical methodologies, analytical method development and validation.
- Industry experience in the establishment of quality systems compliance within the above field(s).
- Minimum of one (1) year of people management experience.
- Willing and able to travel approximately 10% domestically and internationally.
- Extensive knowledge of FDA regulations pertaining to cGMP requirements and be proficient with regulation and guideline interpretation, audit procedures, proper documentation, and quality assurance and departmental policies and procedures.
- 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.
- Possesses a certificate 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 verbal and written communication skills.
- Able to speak, read and/or understand a foreign language.
- Able to deal with multiple changing priorities and work with minimal supervision.
- Having demonstrated effective and efficient project management and people management experience.
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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular