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
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
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
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.
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.
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Job Category Promoting the Quality of Medicines