OBJECTIVES OF THE PROGRAMME

The Regulation and Prequalification Department (RPQ) works with Member States and partners to improve the access to essential medicines and other health technologies of assured quality, safety and efficacy or effectiveness. RPQ works within the Access to Medicines and Health Products Division (MHP) division departments in the wider framework of Universal Health Coverage and category 4 of the General Programme of Work and cooperates with disease oriented programmes (among others HIV/AIDS, TB, malaria, reproductive health, maternal and child health, immunization, NCDs and mental health) towards the Sustainable Development Goals. The department works with a wide range of UN organizations, international partners and expert networks, and WHO Collaborating Centres.The objective of the Regulation and Safety (REG) unitin RPQ is to support all Member States to strengthen their capacity so that they will have regulatory systems to ensure that all medical products and other health technologies on their markets meet internationally recognized standards of quality, safety and efficacy.

Description Of Duties

Oversees, coordinates and expands the WHO-Network of National Control Laboratories for Biologicals (NNB) with the aim to promote reliance and harmonization of regulatory practices and create a forum supporting global collaboration and exchange.
Promotes, initiates and oversees the development of agreements with manufacturers regarding sharing of essential quality, safety and efficacy data of prequalified or EUL listed vaccines with the WHO and the NNB members.
Maintains a secure Network Sharepoint for confidential data exchange within the WHO-NNB as well as an information management system related to testing of vaccines.
Facilitates accelerated access to quality vaccines and other biological medicinal products through promoting collaboration and liaising with stakeholders (UN procuring agencies, WHO Regional Offices and Country Offices, manufacturers, Member States, health authorities and governmental institutions).
Coordinates and oversees relevant international collaborative studies and proficiency testing related to vaccine quality testing.
Provides senior level advice, coordinates and contributes to technical assistance and technical advice to NCLs (advocacy activities, information sharing, harmonization of tests/methodologies) for compliance with standards and proficiency in relevant test methodologies.
Monitors, evaluates and coordinates the laboratory testing as part of the vaccine assessment prequalification processes and on demand – post-prequalification quality monitoring of vaccines, and organizes audits of contracted laboratories, and manages the record keeping.
Contributes to the RPQ quality management system through drafting and maintenance of the LNS team SOPs related to the area ofwork.
Supports implementation of institutional development plans following benchmarking of laboratory testing and lot release regulatory functions in close collaboration with relevant REG Unit team.
Interacts with WHO Regional and Country Offices, regulatory authorities and governmental institutions in Member States as and when required.
Performs other related duties as requested by the team lead and/or unit head, for example contributions to grant proposal development and donor reporting, updating the content of relevant webpages.

Required Qualifications

Education

Essential: An advanced level university degree (Masters level or above) in Biology, Pharmacy, Chemistry, Biochemistry, Medicine, Microbiology or related sciences.

Experience

Desirable:

Essential

At least ten years’ experience in the regulation of biological products and the production/control/quality assurance of vaccines and biologicals acquired by working with a National Regulatory Authority(NRA), UN agency or a vaccine manufacturer.
Extensive experience in the production and quality control of vaccines.
Experience in regional and/or international cooperation in the area of quality assurance of vaccines.

Desirable

Demonstrated progressive experiencein quality and safety related regulatory work at international level.
Experience in development and delivery of trainings and/or provision of technical assistance to national control laboratories for biologicals.
Experience in inspections or audits of quality control laboratories for vaccines.

Skills

Scientific background and expertise, particularly in the area of infectious diseases and vaccines.
Extensive knowledge of regulatory affairs, production and quality control of vaccines.
Knowledgeable of relevant ISO Standards 17025 and 9001.
Understanding of relevant GxPs.
Knowledge about required competencies of laboratory staff in quality control laboratories for biologicals.
The ability to work in a highly culturally diverse environment.
Ability to manage a project in international settings.

WHO Competencies

Teamwork
Respecting and promoting individual and cultural differences
Communication
Producing results
Building and promoting partnerships across the organization and beyond

Use of Language Skills

Essential: Expert knowledge of English.

Desirable: Beginners knowledge of French.

REMUNERATION

WHO salaries for staff in the Professional category are calculated in US dollars. The remuneration for the above position comprises an annual base salary starting at USD 90,664 (subject to mandatory deductions for pension contributions and health insurance, as applicable), a variable post adjustment, which reflects the cost of living in a particular duty station, and currently amounts to USD 5553 per month for the duty station indicated above. Other benefits include 30 days of annual leave, allowances for dependent family members, home leave, and an education grant for dependent children.

Additional Information

This vacancy notice may be used to fill other similar positions at the same grade level
Only candidates under serious consideration will be contacted.
A written test may be used as a form of screening.
In the event that your candidature is retained for an interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
Any appointment/extension of appointment is subject to WHO Staff Regulations, Staff Rules and Manual.
Staff members in other duty stations are encouraged to apply.
For information on WHO’s operations please visit: http://www.who.int.
WHO is committed to workforce diversity.
WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
WHO has a mobility policy which can be found at the following link: http://www.who.int/employment/en/. Candidates appointed to an international post with WHO are subject to mobility and may be assigned to any activity or duty station of the Organization throughout the world.
Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.

Grade

P5

Contractual Arrangement

Fixed-term appointment

Contract Duration (Years, Months, Days)

One year

Job Posting

Sep 2, 2022, 1:01:00 PM

Closing Date

Sep 23, 2022, 10:59:00 PM

Primary Location

Switzerland-Geneva

Organization

HQ/RPQ Regulation and Prequalification

Schedule

Full-time

IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device’s system settings.