Pharmaceutical quality control and assurance, medical technology quality control and assurance, supply chain, quality assurance policy, pharmaceutical regulation, medical procurement.

UNITAR is an autonomous body within the United Nations that was established in 1965 pursuant to a UN General Assembly resolution. UNITAR’s mission is to develop the individual, institutional and organisational capacities of countries and other United Nations stakeholders through high quality learning solutions and related knowledge products and services to enhance decision-making and to support country-level action for overcoming global challenges.

The Defeat-NCD Partnership is the practical response to the widespread call for action on NCDs. Formally launched during the United Nations General Assembly in New York on 24th September 2018. The Defeat-NCD Partnership is a ‘public- private-people’ partnership anchored in the United Nations but extending well beyond to include governments, multilateral agencies, civil society, academia, philanthropies, and the private sector.

The Defeat-NCD Partnership’s vision is that of a world in which there is universal health coverage for NCDs. This is a direct contribution to the transformational 2030 Agenda for Sustainable Development to which all nations have subscribed.

The Defeat-NCD Partnership’s mission is to enable and assist approximately 90 low resource countries, in its initial scope, to scale-up sustained action against NCDs so that they can progress on SDG 3, ensuring healthy lives and promoting well-being for all at all ages” and, more specifically, to achieve target 3.4 to “reduce, by one-third, premature mortality from NCDs by 2030″.

The Defeat-NCD Partnership’s practical work is organised around four interconnected pillars that, taken together, constitute a comprehensive service package to tackle the most common gaps and constraints that challenge low-resource countries.

The Partnership four pillars of work include:

1. National NCD Capacity Building: to ensure that partner countries have essential institutional capacities, structures, systems, and financing in place to tackle NCDs in a sustained and sustainable manner.
2. Community Scale Up of NCD Services: to bring more of the necessary prevention and management of NCD services directly to more people who need them.
3. Affordability and Accessibility of Essential NCD Supplies (The Defeat-NCD Partnership Marketplace): to enable the consistent provision of affordable essential NCD medicines, diagnostics, and medical equipment and supplies in low resource countries.
4. Financing for Country Level NCD Programming: to establish a long-term sustainable financing model for NCD programming in low resource countries.

A pervasive problem for resource-poor countries is the high cost (relative to income) and precarious availability of essential quality NCD Medicines, Diagnostics, Medical Equipment and Supplies.

To tackle this, The Defeat-NCD Partnership is designing a Marketplace to make the provision of quality assured essential NCD supplies simpler and more cost-effective. With market-sizing and price-tracking studies conducted in low resource countries, the Marketplace will address current market failures due to information imbalances and create a competitive environment that serves the fair interests of both buyers and suppliers, while bringing transparency to the process.

The Defeat-NCD Partnership Marketplace is set up to ensure access to quality-assured NCD medicines, diagnostics, medical equipment and supplies by employing innovative business approaches, efficient knowledge management for evidence-driven leadership in market management, strategic procurement, and high-quality procurement and supply services to client countries.

 In view of the above, there is a need to quickly assess country quality standards and regulatory requirements when procuring NCD medicines, diagnostics, medical equipment and supplies, including under current or foreseen domestic financing and procurement. Implications of financing, procurement, and supply chain practices must be articulated, including projections on how certain scenarios may affect both public health and market outcomes. Clear recommendations are needed to guide the Defeat-NCD Partnership country programmes and external funding agencies on the best practices to ensure continued access to and scale-up of quality assured NCD medicines, diagnostics, medical equipment and supplies to ensure sustainability of an affordable, quality-assured drugs and diagnostics.

Within delegated authority and under the guidance of the Market Shaping Specialist, the Quality Assurance Consultant is responsible for the following duties:

• Carry out an in-depth analysis of the quality assurance policies of donors and other international procurement mechanisms related to NCD medicines, diagnostics, medical equipment and supplies;
• Review processes/standards of key regulatory authorities and international review processes including the European Union, FDA, World Health Organization’s (WHO) prequalification of medicines and In Vitro diagnostics (IVDs) and other Diagnostics; 
• Collect information and if necessary, conduct phone interviews with National Regulatory Authority representatives of the Defeat-NCD Partnership programme countries (maximum of 10; the list of countries to be agreed upon) to understand country quality standards and regulatory requirements when procuring NCD medicines, diagnostics, medical equipment and supplies;
• Draw up the quality assurance policy for NCD medicines, diagnostics, medical equipment and supplies including medical devices and general laboratory supplies. The final policy document must be in line with the Model Quality Assurance Policy for Procurement Agencies and consider relevant WHO, key donor, and technical agency guidelines;
• Work with Partners towards harmonisation of quality assurance policy for medicines, diagnostics, medical equipment and supplies and approaches to respond to countries public health program needs for access to quality assured products;
• Develop the Defeat-NCD Partnership quality monitoring programme for NCD medicines, diagnostics, medical equipment and supplies including pre-shipment inspection of consignments, sampling, and quality testing;
• Develop standard operating procedures and critical metrics to implement and supervise the efficiency the Defeat-NCD Partnership quality assurance policy.

Output 1: Develop a consolidated report from the compilation of current quality standards of selected Key international regulatory bodies for NCD medicines, diagnostics, medical equipment and supplies; an analytical review of the processes of these agencies and imminent changes, if any, in the regulatory environment to the extent these can be assessed. To be delivered by 14 August 2021 or an earlier agreed date. 

Output 2: Develop consolidated report including an overview of quality requirements for procurement by countries based on the interview outcomes for NCD medicines, diagnostics, medical equipment and supplies (including IVDs, medical devices and general laboratory supplies) for selected NCD partner countries (minimum 7) together with a report detailing their individual requirements. To be delivered by 14 September 2021 or an earlier agreed date.

Output 3: Develop a consolidated quality assurance policy for the Defeat-NCD Partnership Marketplace. To be delivered by 14 October 2021 or an earlier agreed date.

Output 4: Prepare the Defeat-NCD Partnership quality monitoring programme, standard operating procedures, and critical metrics to implement the Defeat-NCD Partnership quality assurance policy. To be delivered by 14 November 2021 or an earlier agreed date.

• Timely and quality submission of deliverables.
• Activities implemented with a high degree of effectiveness and efficiency.
• High degree of professionalism demonstrated by the consultant.

• Understanding of data privacy standards; integrity; honesty; customer-service skills.
• Solid communication skills, both written and verbal.
• Familiarity with supply chain and quality assurance principles and practices with superior attention to detail.
• Organisational skills; planning skills; problem-solving skills; analytical skills; critical thinking skills.
• Computer skills, particularly with spreadsheets and calculation software.
• Ability to organize effectively, work under pressure with attention to detail, precision and accuracy.
• Demonstrated ability to work harmoniously with persons of different national background.
• Proficiency level in organising audio and video conferences.

The incumbent will report to the Technical Specialist (Country Support)

US$ 20,000. Payment under the contract will be output based and will be made upon satisfactory completion and acceptance of the deliverables, as outlined below:

Amount               Date of payment

US$ 5,000 - Upon satisfactory receipt of deliverable number 1

US$ 5,000 - Upon satisfactory receipt of deliverable number 2

US$ 5,000 - Upon satisfactory receipt of deliverable number 3

US$ 5,000 - Upon satisfactory completion and certification of work

General conditions of contracts for the service of Consultants apply.

Consultants are responsible for determining their tax liabilities and for the payment of any taxes and/or duties, in accordance with local laws. UNITAR does not reimburse Consultants for any taxes, duty, or other contribution payable by the Individual contractor on payments made under the Consultant.

The Institute does not provide or arrange life or health insurance coverage for Consultants, and Consultants are not eligible to participate in the life and health insurance schemes provided by the UN for its staff members.

a. Education

• An advanced university degree (master’s or equivalent) in health-related field such as medicine, pharmacy, biology, public health, epidemiology, or other filed related to the job description.  
• A degree in social sciences and/or engineering may also be considered relevant if supported by relevant experience of 7 years or more.
• A First level university degree (bachelor’s or equivalent) in combination with 9 additional years of relevant experience may be accepted in lieu of an advanced university degree.
• Quality assurance and quality control diplomas especially for medical products would be an important asset.

b. Work Experience

• A minimum of 7 years of experience in quality assurance of healthcare commodities in the public health sector, ideally in procurement and supply chain management (PSM) of healthcare products including and not limited to product quality assurance is required.
• Experience in pharmaceutical drugs and medical technology quality management in general, and familiarity with the implementation and application of ISO 9001, ISO 13485 in required.
• Experience in dealing with regulatory issues of medical devices and in vitro diagnostic medical devices, preferably in one of the 5 GHTF (Global Harmonization Task Force) founding countries: EU, Japan, Australia, Canada, and USA is required.
• Experience in implementation of various standards, directives, regulations relevant to compliance with EU MDD/MDR and IVD/IVDR is required.

c. Languages

• Excellent knowledge of English with proven ability to communicate in English (spoken and written) in a clear and concise manner.
• Working knowledge of another United Nations official language is preferred.

• Experience in developing QA policies and guidance documents for drugs and diagnostics is desired.
• Experience in Public Health Procurement and Supply Chain management of health products is desired.
• Knowledge of mechanisms of WHO Prequalification Programme for Drugs and IVDs is desired.
• Experience with international donors and organizations, specifically with WHO and UN agencies, International NGOs active in Public Health, and/or private sector companies is desired.