USP seeks a Quality Assurance & Quality Control (QA/QC) consultant with expertise in working with NRAs and implementing the ISO 9001 standard 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, and developing strategy to strengthen local production of medicines and vaccines. The expert should be bilingual with a strong background in establishing and implementing QMS at country and regional levels, with proven ability to deliver training, provide technical assistance, conduct assessments, and mentor regulatory and quality assurance teams. The position requires solid knowledge of ISO 9001 standards, other key related ISO standards (eg ISO 17025, ISO 13485, ISO 15189) and other related WHO good practices. The expert should also have demonstrated experience in strengthening medicines quality assurance systems through technical assistance and donor-funded programs.
**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:
Developing training materials and facilitator’s guides for defined QMS training.
Developing pre- and post-test questions for defined laboratory QMS training.
Delivering defined QMS training and evaluating the performance of the trainees.
Providing technical assistance to NRAs to implement QMS (e.g., ISO 9001).
Providing technical assistance to NQCLs to implement QMS (e.g., ISO 17025, ISO 13485, ISO 15189).
Providing supportive assistance for laboratory QMS implementation.
Providing mentorship and coaching to NRA/NQCL Quality Assurance teams.
Implementing the laboratory program unit’s laboratory systems strengthening approach.
Providing technical support to NRAs on laboratory testing and national regulatory systems functions to reach WHO GBT Maturity Level 3.
Serving as a technical resource among USP technical RSS staff on laboratory QMS activities.
Participating in the development of in-house training programs to ensure sustainability and transfer of knowledge.
Providing inputs in the development of USP technical approach tools.
Preparing technical and trip reports.
Qualifications
Master’s degree in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or a related field.
Eight (8) years’ experience in pharmaceutical regulation, regulatory functions, and particularly in QMS.
Ability to travel for up to 25% of the time (if applicable)
Excellent written and oral communication skills, including experience in training and mentoring staff and others
Strong written (especially technical writing) and oral communication skills in both English and French.
Resides in the Africa Region (Please specify countries of experience)
Solid knowledge and understanding of the norms and practices of pharmaceutical systems in Africa
Knowledge of and experience with: Pharmaceutical systems in Africa ISO 9001:2015, ISO/IEC 17025:2017, ISO 15189:2012, ISO 13485 and WHO Good Practices for Pharmaceutical Quality Control Laboratories, WHO Global Benchmarking Tool and other laboratory QMS assessment tools.
Hands-on experience in establishing, implementing and maintaining Quality Management Systems at country and regional levels.
Preferred Qualifications
Demonstrated experience working in key functions in an NRA or organization providing technical assistance to strengthen medicines quality assurance systems.
Direct experience implementing donor-funded programs
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 24, 2025. When submitting your applications, please write “QA/QC – ISO 9001 (Africa Region)” 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 have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
