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The U.S. Pharmacopeial Convention (USP) Technical Officer, Regulatory Systems Strengthening- Bangladesh in United States

Technical Officer, Regulatory Systems Strengthening- Bangladesh

Promoting the Quality of Medicines

Dhaka

ID:1620-679

Full-Time/Regular

The Technical Officer, Regulatory Systems Strengthening (RSS) will provide technical assistance to the Directorate General of Drug Administration’s (DGDA) to build their capacity to regulate the Bangladesh pharmaceutical market. They must possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries. As the lead for PQM+ Bangladesh in RSS, the Technical Officer provides technical oversight related to the program’s objective of strengthening regulatory capacity. Additionally, he/ she acts is a recognized leader, interfacing with DGDA and stakeholders involved in supplying and manufacturing quality essential medicines.

Roles and Responsibilities

  • Leads the roll-out of risk-based post marketing surveillance and the uptake and application of the MedRS tool

  • Provide technical assistance for ISO 17025 accreditation and/or WHO prequalification by assessing, auditing, preparing and reviewing Quality Management System (QMS) documents, and providing necessary training for onsite staff.

  • Assist in preparation of quality control laboratories for WHO inspections, including assistance in strengthening QMS procedures to prepare for WHO inspections, conducting of mock audits and preparation of laboratory information files to be submitted to WHO.

  • Assist the laboratories during WHO inspections, assist in development of CAPA plans after WHO’s PQ inspections, and support in their implementation.

  • Provides technical oversight of activities to support the DGDA

  • Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge

  • Provide oversight for local RSS staff, local partners and consultants involved in the regulation medical products

  • Keep abreast of the latest regulatory trends and WHO guidance

  • Technical point of contact for local WHO office

  • Develops institutional development plans to address findings from WHO Global benchmarking assessments

  • Manages and mentors junior technical staff

  • Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports

Basic Qualifications

  • Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required

  • 6 + years of experience implementing USAID-funded programs leading and providing technical assistance programs to medicine regulatory authorities (MRAs) and manufacturers to ensure the availability of quality medical products.

  • 2+ years people management experience and skills

Preferred Qualifications

  • Direct experience with and understanding of WHO global benchmarking tool and WHO prequalification of medicines program

  • Experience at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH

  • Working knowledge and understanding of regulatory systems strengthening in Bangladesh

  • Strong written (especially technical writing) and oral communication skills

  • Willingness to travel at least 25% of the time.

Supervisory Responsibilities

Reports will scale with program growth and will include relevant technical staff

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 Category Promoting the Quality of Medicines

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