Under the supervision and overall guidance of the Unit Head, Local Production and Assistance (LPA) Unit, the incumbent will work with relevant colleagues to:

• Organize and/or provide WHO PQ/EUL-related specialized technical assistance for up to 5 manufacturers with on-site/virtual training and/or technical assistance on the quality/CMC, non-clinical and/or clinical aspects, post-marketing safety obligations including RMP and collection of AEFIs, and dossier of vaccines and other biotherapeutic products and prepare the relevant materials (e.g. reports, concept note, agenda…).
• Contribute with technical input for standard operation procedures for provision of WHO PQ-related specialized technical assistance to manufacturers of vaccines and other biotherapeutic products, or other LPA-related activities (e.g. organizing training) and prepare the relevant documents (e.g. SOP documents).
• Facilitate organizing and/or conducting on-site reviews of dossiers of vaccines and/or biotherapeutic products for compliance with current WHO/international on standards and requirements of quality, non-clinical, clinical and/or post-marketing safety, including for WHO PQ/EUL, to up to 2 countries and prepare the relevant documents, materials (e.g. reports…).
• Organize and conduct at least 1 capacity building activities and technical assistance activities, for relevant stakeholders in the areas of CMC/quality, non-clinical, clinical and/or post-marketing safety documentation etc. of vaccines and/or biotherapeutic products with the relevant documents (e.g., concept note, agenda…) and prepare the relevant documents (e.g. concept note, agenda…).
• Facilitate the preparation of training materials related on the quality/CMC, non-clinical, clinical and/or post-marketing safety aspects of vaccines and/or other biotherapeutic products and delivery of relevant training materials
• Contribute with technical inputs on the technical products of the LPA Unit, such as” frequently asked questions” documents, with collaboration from relevant colleagues and prepare of relevant documentations (e.g., FAQ…).

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:

Advanced university degree in pharmacy, health sciences, life sciences, or other science or health related fields.

Desirable:

Advanced university degree related to development, production, safety profile and/or clinical performance assessment of vaccines and/or biotherapeutic products, such as public health, vaccinology, immunology, biochemistry, cellular biology or biotechnology.

Experience:  

Essential:

At least seven years of relevant experience, some of which at the international level, in the production, CMC, quality control, non-clinical and/or clinical development, post-marketing safety documentation and dossier preparation for vaccines and/or biotherapeutic products under current international quality standards.

Desirable:

Relevant professional experience in the manufacturing industry of medical products or their regulatory control including:

Experience in a national regulatory authority as a CMC/quality, non-clinical, clinical and/or pharmacovigilance assessor of vaccines/biotherapeutic products.

Experience with the WHO Prequalification and/or Emergency Use Listing procedures.

Experience in organizing and/or providing capacity building/training for development, manufacturing, and regulation of medical products in low- and middle-income countries.

Experience in technology transfers.

Experience in an international organization.

Skills: 

Essential:

• Strong knowledge of the manufacturing processes, CMC, non-clinical and/or clinical development, post-marketing safety documentation and product dossier requirements of vaccines and/or biotherapeutic products in accordance with WHO and/or internationally recognized standards.
• Knowledge of current WHO and other internationally recognized quality assurance standards, WHO emergency listing and/or prequalification procedures and/or health product regulation for vaccines and/or biotherapeutic products.
• Ability to review, revise or develop technical documents and activities in the area of local production of medical products.
• Ability to design, plan and implement activities to achieve the goal(s).
• Excellent communication and interpersonal skills, strong planning and organizational skills and ability to use a range of IT tools (Word, Excel, presentation software, databases and web navigators).
• Demonstrated ability to interact with all stakeholders with tact and diplomacy, upholding the reputation of the Organization at all times.

Desirable:

• Knowledge of current WHO and/or other internationally recognized standards of GMP and/or quality management systems of manufacturing facilities of vaccines and/or biotherapeutic products.
• Knowledge of technology transfers for vaccines and/or biotherapeutic/pharmaceutical products.
• Knowledge of the CMC, non-clinical and/or clinical development, post-marketing safety, GMP and/or product dossier requirements of medicines in accordance with WHO and/or internationally-recognized standards.

Languages required:

Essential:

Expert knowledge of English.