JOB DESCRIPTION

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1. Purpose of consultancy

The purpose of this consultancy is to review the current Quality Management System (QMS) of the National Regulatory Authority (NRA) in Jordan (JFDA), conduct a root cause analysis of the existing situation, identify gaps, and provide technical support and guidance to develop and upgrade the current QMS. This will be done in alignment with WHO guideline on the implementation of QMS for national regulatory authorities.

Objective 1: Provide support for the implementation of a QMS according to WHO guidelines, ISO 9001 and ISO 17025 standards for institutions involved in the regulatory system for medicines including the delivery of a training program.

Objective 2: Assist the various structures constituting the regulatory authorities for medicines and vaccines in the preparation of an action plan for the implementation of the QMS of the national agency for medicines and health products.

Objective 3: Support the above-mentioned structures in the implementation and monitoring of the activities of the Institutional Development Plan (IDP) in relation to the QMS.

2. Background

The World Health Organization (WHO) plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safety, efficacy, and affordable medical products and health products. The WHO constitution affirms that enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. Towards the achievement of such a noble objective, the WHO constitution states the functions of WHO, which include among others, assisting governments, upon request, in strengthening health services. Various world health assembly (WHA) resolutions encompass aspects of the need to promote the WHO role. It should be noted that regulators are an essential part of the health workforce and effective regulatory systems are an essential component of health systems and contribute to better public health outcomes. On the contrary, inefficient regulatory systems themselves can be a barrier to accessing safe, effective and quality medical products.

WHO mandated by resolution WHA 67.20, supports countries to strengthen regulatory systems by:

• building regulatory capacity in member states consistent with good regulatory practices, and

• promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.

Benchmarking activities involve the evaluation of the medical products’ national regulatory system using the WHO Global Benchmarking Tool (GBT), generating and analyzing evidence of regulatory systems performance and facilitating the formulation of Institutional Development Plans (IDPs) as a set of recommendations for the National Regulatory Authorities (NRAs) of member states.

3. Work to be performed

Output 1:

Deliverable 1.1: Prepare a methodological note describing the proposed approach to delivering the support to the JFDA.

Deliverable1.2: Review the current Quality Management System (QMS), procedures, policies and regulations, of the National Regulatory Authority (JFDA).

Deliverable 1.3: Conduct an assessment and gap analysis of the QMS at the institutions involved in the national regulatory system for medicines and vaccines; to identify gaps and areas for improvement.

Deliverable 1.4: Develop an action plan for the implementation of a QMS (according to WHO guidelines, and ISO 9001 and ISO 17025 standards), including the link with the requirements required by the WHO GBT to achieve maturity level 3 at least.

Deliverable 1.5: Review of the current organizational structure (organogram) related to the implementation of the QMS at JFDA. Provide practical recommendations and guidance to ensure the establishment of an effective and functional QMS, aligned with international standards and best practices.

Deliverable 1.6: Conduct a QMS training workshop for JFDA staff on the l concepts for implementing a QMS, based on the updated WHO guidelines for the implementation of quality management systems in national regulatory authorities.

Deliverable 1.7: Provide ongoing and remote technical support and guidance to upgrade and update JFDA QMS and assist the various institutions constituting the national regulatory authority in implementing and continuously improving their QMS in alignment with WHO standards and best international practices.

Output 2:

Deliverable 2.1: Provide assistance and monitor the implementation of the Quality Management System (QMS) across the various departments involved in the national regulatory system for medicines. This includes regular follow-up for the period of the consultancy on QMS activities in relation to the Institutional Development Plan (IDP) and previous recommendations, through both remote support and on-site visits.

Deliverable 2.2: Conduct on-ground training sessions and provide technical support and guidance to staff on key concepts essential for the effective implementation of a QMS.

Deliverable 2.3: Submit a progress report and final report on the progress and implementation of the QMS, highlighting steps taken and outcomes achieved, with the goal of enabling JFDA to attain Maturity Level 3 or higher under the WHO Global Benchmarking Tool (GBT) programme.

4. Qualifications, experience, skills and languages

Educational Qualifications:

Essential: Master”s degree in quality management or in pharmacy, medicine, pharmacology, chemistry, biochemistry, microbiology, or other health-related sciences.

Desirable: Postgraduate degree in quality management system in the area of regulation and/or production of medical products, particularly medicines and biologicals.

Experience:

Essential:

· At least 10 years of professional experience in the regulation of medical products, preferably within a national or regional regulatory authority or a related field.

· 5–10 years of experience in the design, training, implementation, support, and certification of Quality Management Systems (QMS), in accordance with ISO 9001 and ISO 17025 standards.

· Proven track record with documented references from institutions or organizations that have received training and support for QMS implementation.

· Extensive experience in delivering similar international consultancy, with tangible outcomes.

Desirable:

· Previous collaboration with the World Health Organization (WHO) and deep knowledge of regulatory system strengthening and WHO global benchmarking tool.

· Familiarity with the Jordanian national regulatory system for medicines.

Skills/Technical skills and knowledge:

· Expertise in regulatory systems strengthening medical products within national regulatory authorities or related fields and experience on the use of GBT.

· Excellent communication skills and proven ability to work effectively in diverse cultural, institutional settings, particularly in low-and middle-income countries and managing multiple tasks simultaneously with timely delivery.

· Advanced computer literacy, including proficiency in regulatory IT systems and databases.

· High-level drafting, analytical, and interpersonal skills, with the ability to convey complex concepts clearly.

· Demonstrated capacity to train, mentor, and motivate staff at various levels.

Languages and level required:

· Excellent command of English and ability to communicate effectively.

· Communication in the Arabic language is desirable.

5. Location

Amman – Jordan (On-site).

6. Planned timelines (Subject to confirmation)

35 working days

Start date: 3 August 2025

End date: 31 December 2025

7. Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

8. Travel

The Consultant is expected to travel according to the itinerary and estimated schedule below:

Travel dates				Location: Amman-Jordan
From	06/07/2025	To	15/07/2025
Purpose:		– Review the current provision of the JFDA. – Conduct an assessment and gap analysis of the QMS at the institutions involved in the national regulatory system for medicines. – Conduct a QMS training workshop for JFDA staff.

Travel dates				Location: Amman-Jordan
From	14/09/2025	To	16/09/2025
Purpose:		– Monitoring the implementation of the Quality Management System (QMS) across the various departments in the JFDA and measure the progress. – Conduct on-ground training sessions and provide technical support and guidance to staff on key concepts essential for the effective implementation of a QMS. – Provide technical support and guidance to upgrade and update the national QMS and assist the various institutions constituting the JFDA. – Provide technical support and guidance related to Marketing Authorization and Post-Marketing Surveillance (PMS).

Travel dates				Location: Amman-Jordan
From	07/12/2025	To	09/12/2025
Purpose:		– Monitoring the implementation of the Quality Management System (QMS) across the various departments in the JFDA and measure the progress. – Provide technical support and guidance to upgrade and update the national QMS and assist the various institutions constituting the JFDA.

** The actual number of days required for travel to Jordan and the detailed schedule will be determined in coordination with the responsible WHO officer.

All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.

Additional Information

· This vacancy notice may be used to identify candidates for other similar consultancies at the same level.

• Only candidates under serious consideration will be contacted.
  
• A written test may be used as a form of screening.
  
• If your candidature is retained for 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.
  
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The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.

Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to [email protected]

· An impeccable record for integrity and professional ethical standards is essential. 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 (https://www.who.int/about/who-we-are/our-values) 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 short-listed candidates.
  
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• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority.
  
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Level of Education: Bachelor Degree

Work Hours: 8

Experience in Months: No requirements