PQM+ is providing support to the U.S. Government initiative for Global Vaccine Access, supporting six countries in Africa- Ghana, Kenya, Nigeria, Rwanda, Senegal, and South Africa. The program aims at helping such poised countries to produce vaccine domestically. This is to be accomplished by strengthening their medicine regulatory capacity, supporting technology transfer, improving local manufactures’ readiness, as well as strengthening their national medicine quality assurance systems.
PQM+ is currently recruiting for consultant(s), to provide technical assistance to National Medicine Regulatory Authorities (NMRAs) and to National Quality Control Laboratories (NQCLs) to support the local production of quality-assured vaccines, especially COVID-19 vaccine. The consultant will help build national regulatory capacity for vaccines as well as the workforce competency for biologics and vaccines quality assurance. S/He will serve as a subject matter expert using knowledge to ensure cGMP compliance, fulfillment of technical requirements and regulatory guidelines as they relate to fill/finish and packaging equipment, materials, facilities, and process development.
The consultant is expected to support one of the target six countries and may provide additional targeted assistance to any one or more of the other five countries. The consultant will be located in one of the six countries and will report to the PQM+ respective in-country Chief of Party or his/her designee and will work collaboratively under technical guidance and oversight of the HQ Rockville-based Vaccines Director.
Key Responsibilities
· Guide the technical development and implementation of in-country COVID-19 vaccine manufacturing and regulatory work plan activities
· Provide support to strengthen National Medicines Regulatory Authorities (NMRAs) legal framework for vaccines manufacturing, supply, storage, distribution, and handling
· Support NMRAs and national control labs in the development of lot release testing capacity and in the implementation of vaccine post-marketing surveillance. Also support the GMP inspectorates of NMRAs to strengthen their capacity for regulatory oversight of vaccine manufacturers.
· Provide assistance in the formulation of medicines regulation guidelines to improve quality and safety of vaccines in line with the national regulatory system
· Support and coordinate regulatory assessment activities and support the development and implementation of Institutional developmental plans for the different NMRAs functions.
· Liaise with HQ Vaccines Director, other staff, and consultants for the development of appropriate training materials and to organize the delivery of training programs targeted to local vaccine manufacturers, regulators, and quality laboratory staff.
· Support manufacturers in addressing deviations and non-compliances, in conducting audits to assess compliance and the establishment of cGMPs; also, in filing of vaccine dossiers for market authorization according to NMRAs’ requirements.
· Coordinate efforts aimed at the identification of needs for manufacturing and laboratory equipment, materials, and processes in support to successful local production and quality assurance of COVID-19 vaccines.
· Partner with USP and PQM+ technical team members, consultants, other PQM+ countries, vendors, and local stakeholders to assure adequate manufacturing facility design and startup, whenever this may be required.
· Provide technical assistance to COVID-19 mRNA vaccines manufacturers on development, commissioning, qualification and validation of vaccine fill/finish and packaging processes.
· Support the development of technical and communication materials related to local manufacturing, regulation and quality of vaccines.
· Collaborate and attend meetings with relevant stakeholders and donors including USAID as needed.
Deliverables
· Weekly activity summaries, detailed monthly activity reports and monthly deliverables as assigned, which are required for consultancy payments.
· Technical reports or documents when applicable
· Other deliverables as requested
Qualifications and Experience
· Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, biochemistry, engineering, or science related field of study required
· Master’s degree in pharmaceutical sciences/pharmaceutical quality assurance and quality control of medicines preferred
· At least 8 years of experience in vaccines and biologics either within a pharmaceutical manufacturing company or a medicines regulatory authority.
· Subject matter expert in vaccine/biopharmaceutical fill/finish and packaging processes
· Knowledge of regulatory requirements related to the development and manufacture of biologics
· Strong communication skills and fluent in spoken and written English language.
· Fluency in English language is required
· Experience working with USAID projects preferred.
· Results driven with demonstrated successful outcomes
· Must possess ability to work independently and handle multiple priorities in a fast-paced environment
· Ability to demonstrate the highest degree of ethics and integrity.
Period of Performance
Please send CV, 3-References, and Hourly Rate to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of 7/15/2022
When submitting your application, write “” Vaccine Manufacturing Consultant” and the name of the country you wish to be considered for, in the email Subject Line.
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.
USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. The Promoting the Quality of Medicines Plus (PQM+) program, implemented by USP, is a U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance (QA) systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance (TA) to build in-country capacity of medical products regulatory authorities’ QA systems in assisted countries. PQM+ also provides technical support to manufacturers to promote quality-assured priority medical products including those used for the prevention, diagnosis, and treatment of COVID-19.