USP seeks a consultant to serve as a Technical Lead for a potential 3-year project in DRC, where USP will provide assistance towards strengthening the maturity level of the National Pharmaceutical Regulatory Authority (ACOREP), strengthening capacities of the National Quality Control Laboratory (NQCL), and developing strategy to strengthen local production of medicines and vaccines. The Technical Lead will provide overall technical direction to a team of regulatory experts, overseeing the development of technical materials (e.g. regulatory documents, training and workshop materials and technical reports) and the delivery of technical assistance to ACOREP and its NQCL. S/He will also deliver specific direct technical assistance during the execution of this project.
**This opportunity is connected to a proposal. Any consultant engagement is contingent upon contract award.**
Roles and Responsibilities
Potential tasks that the consultant/vendor will be responsible for carrying out include:
· Operations and task management: The Technical Lead strategically assigns tasks to team members based on their individual skills and the project schedule to ensure that the team’s performance adheres to agreed upon quality standards.
· Communication and reporting: The Technical Lead serves as the primary liaison between the technical team and the Project Lead. The Technical Lead reports on progress, challenges, and any evolving risks to the technical deliverables to internal management.
· Technical and functional: The Technical Lead provides expertise related to product manufacturing, product quality, drug registration, information systems and regulatory oversight. The Technical Lead monitors work and ensures final work products meet quality standards and provides or identifies training and development opportunities for team members. The Technical Lead will also deliver direct technical assistance to the beneficiary in specific subject matter areas.
· Risk management: The Technical Lead, working closely with the project team and ensures that that the technical experts adhere to the clients expectations of the technical deliverables.
Qualifications
· At least a master’s degree in pharmacy, regulatory affairs, public health, pharmaceutical science or a related field.
· At least ten (10) years of professional experience in regulatory system strengthening, including quality control of medical products (drugs, medical devices, and vaccines/biologics).
· At least 5 years’ experience in the technical management of projects aimed at strengthening national regulatory authorities in accordance with international standards, WHO global benchmarking, WHO prequalification, ISO 9001, and ISO 17025.
· At least 5 years of international experience in managing teams responsible for strengthening pharmaceutical regulatory authorities and national drug quality control laboratories.
· Good knowledge of the certification criteria for a national regulatory authority in accordance with ISO 9001:2015, and good knowledge of the functions of a national regulatory authority.
· Excellent written and oral communication skills, including experience in training and mentoring staff and others
· Fluency in French and English is required.
· Solid knowledge and understanding of the norms and practices of pharmaceutical systems in Africa
· Resides in the Africa Region (Please specify countries of experience)
Preferred Qualifications
· Model Law on Medical Products Regulation, especially its domestication in African countries.
· Ability to travel internationally for up to 25% of the time.
· Experience in training and mentoring staff and others
Application Procedure Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org, by the closing date of October 23, 2025. When submitting your applications, please write “Technical Lead (DRC)” in the email Subject Line of your email.
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. USP’s Global Health programs works with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.