Consultant to provide technical support to review the current Quality Management System (QMS) of the National Regulatory Authority (NRA) in Jordan (JFDA)

Tags: English language Environment
  • Added Date: Wednesday, 16 July 2025
  • Deadline Date: Saturday, 26 July 2025
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Qualifications

1.ย ย ย ย ย ย ย  Purpose of consultancy

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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.

ย 2.ย ย ย ย ย ย ย  Backgroundย ย 

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.ย  The WHO constitution affirms that enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.ย  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.ย  Various world health assembly (WHA) resolutions encompass aspects of the need to promote the WHO role.ย  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.ย  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:

ย โ€ขย ย ย ย ย ย ย ย ย  building regulatory capacity in member states consistent with good regulatory practices, and

โ€ขย ย ย ย ย ย ย ย ย  promoting regulatory cooperation, convergence and transparency through networking, work-sharing, and reliance.

Benchmarking activities involve the evaluation of the medical productsโ€™ 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.ย  ย 

ย 3.ย ย ย ย ย ย ย  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.

๐Ÿ“š ๐——๐—ถ๐˜€๐—ฐ๐—ผ๐˜ƒ๐—ฒ๐—ฟ ๐—›๐—ผ๐˜„ ๐˜๐—ผ ๐—š๐—ฒ๐˜ ๐—ฎ ๐—๐—ผ๐—ฏ ๐—ถ๐—ป ๐˜๐—ต๐—ฒ ๐—จ๐—ก ๐—ถ๐—ป ๐Ÿฎ๐Ÿฌ๐Ÿฎ๐Ÿฏ! ๐ŸŒ๐Ÿค ๐—ฅ๐—ฒ๐—ฎ๐—ฑ ๐—ผ๐˜‚๐—ฟ ๐—ก๐—˜๐—ช ๐—ฅ๐—ฒ๐—ฐ๐—ฟ๐˜‚๐—ถ๐˜๐—บ๐—ฒ๐—ป๐˜ ๐—š๐˜‚๐—ถ๐—ฑ๐—ฒ ๐˜๐—ผ ๐˜๐—ต๐—ฒ ๐—จ๐—ก ๐Ÿฎ๐Ÿฌ๐Ÿฎ๐Ÿฏ ๐˜„๐—ถ๐˜๐—ต ๐˜๐—ฒ๐˜€๐˜ ๐˜€๐—ฎ๐—บ๐—ฝ๐—น๐—ฒ๐˜€ ๐—ณ๐—ผ๐—ฟ ๐—จ๐—ก๐—›๐—–๐—ฅ, ๐—ช๐—™๐—ฃ, ๐—จ๐—ก๐—œ๐—–๐—˜๐—™, ๐—จ๐—ก๐——๐—ฆ๐—ฆ, ๐—จ๐—ก๐—™๐—ฃ๐—”, ๐—œ๐—ข๐—  ๐—ฎ๐—ป๐—ฑ ๐—ผ๐˜๐—ต๐—ฒ๐—ฟ๐˜€! ๐ŸŒ

โš ๏ธ ๐‚๐ก๐š๐ง๐ ๐ž ๐˜๐จ๐ฎ๐ซ ๐‹๐ข๐Ÿ๐ž ๐๐จ๐ฐ: ๐๐จ๐ฐ๐ž๐ซ๐Ÿ๐ฎ๐ฅ ๐“๐ž๐œ๐ก๐ง๐ข๐ช๐ฎ๐ž๐ฌ ๐ก๐จ๐ฐ ๐ญ๐จ ๐ ๐ž๐ญ ๐š ๐ฃ๐จ๐› ๐ข๐ง ๐ญ๐ก๐ž ๐”๐ง๐ข๐ญ๐ž๐ ๐๐š๐ญ๐ข๐จ๐ง๐ฌ ๐๐Ž๐–!

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.

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4.ย ย ย ย ย ย ย ย ย ย  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. ย 

Experience:

Essential:

ยทย 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.

ยทย 5โ€“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.

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

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

Desirable:

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

ยท Familiarity with the Jordanian national regulatory system for medicines.

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Skills/Technical skills and knowledge:

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

ยท 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.

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

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

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

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