Senior GMP Specialist (919-679)
This is a hands-on, non-supervisory position where the incumbent understands the standards and principles of auditing manufacturing facilities for current good manufacturing practice (cGMP) compliance. The incumbent will analyze all elements of a quality system and judging its degree of compliance with the criteria of quality management, evaluation and control systems. The individual leads companies in compiling dossiers for World Health Organization (WHO) prequalification, US FDA’s ANDA, EDQM’s CTD, EMA’s CTD and other dossiers. The incumbent establishes manufacturing, QA, QC process, and documentation requirements for WHO prequalification, USFDA EDQM, EMA and other regulatory programs. He/she partners with the director in the evaluation of cGMP, QA, and manufacturing batch records received from manufacturers. Contributes to qualify pharmaceutical manufacturers for essential drugs supply chain management as well as for generic industry for affordable drugs worldwide.
Roles and Responsibilities:
- Designs and develops work plans and new proposals for submittal to USAID and/or other donors to obtain new funding mechanisms.
- Manages country-specific and/or regional projects for USAID cooperative agreement as assigned by US Missions in different countries.
- Develop training materials and conduct workshops on GMP compliance and product dossier evaluation.
- Identifies and supervises consultants in the different countries who are working for GMP group, if needed.
- Prepares work plans and quarterly progress reports; contributes to annual USAID portfolio review process.
- Explores new opportunities for work in the international arena and for collaboration with other international organizations; develops and drafts proposals for international projects and activities.
- Reviews pre-audit information submitted by pharmaceutical ingredient manufacturers and makes recommendations on the readiness for a formal audit.
- Conducts site audits of drug substance and FPP manufacturing sites as the lead auditor for a team of two.
- Creates final reports summarizing the results of the site audits and makes recommendations to the PQM GMP specialist regarding a site’s compliance with GMP.
- Reviews submitted reports and makes final recommendations to the GMP specialist regarding a site’s compliance with GMP, when contract auditors have been used.
- Prepares final disposition reports combining the audit report and document review for submissions to USAID.
- Develops and updates USP SOP's and policies related to the conducting of GMP audits for compliance.
- Provides input designed to update USP’s “Guidelines for Participants” and other documentation intended to assist current and potential participants in the program offerings.
- Participates in developing and conducting training programs for potential auditors leading to certification.
- Train GMP specialist in Dossier review and GMP audit process.
- Performs other related duties as assigned.
- Bachelor’s degree and seven years of experience in the pharmaceutical industry and/or government drug regulatory authority required. US FDA, EDQM, EMA, TGA and other experience strongly preferred.
- Minimum of five years’ experience conducting GMP inspections.
- 3 years of experience in international programs, developing countries preferred.
- Excellent communication skills MS Word, Excel and PowerPoint skills required
- Ability to travel at least 20-25% of the time both domestic and internationally.
- Knowledge in CGMP drug development to commercialization.
- Knowledge of developing countries for both public health sector and generic pharmaceutical market including testing and manufacturing.
- Excellent verbal, written and presentation skills; grant writing experience helpful.
- Ability to network with professionals from WHO, UNICEF, UNIDO, USFDA, EDQM, EMA, GDF, Global Fund and other donor foundations as well as local in-country representatives and government officials. Ability to work with virtual teams in remote locations.
- Ability to work with nationals from varied backgrounds and cultures. Language skills a plus (English, Spanish, French, Arabic or Mandarin).
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