Quality Assurance Specialist

Copenhagen

Organization: UNDP - United Nations Development Programme
Location: Copenhagen
Grade: Mid level - P-4, International Professional - Internationally recruited position
Occupational Groups:
- Operations and Administrations
- Education, Learning and Training
- Information Technology and Computer Science
- Internal audit, Investigation and Inspection
- Monitoring and Evaluation
- Supply Chain
- Ombudsman and Ethics
- HIV AND HEALTH
Closing Date: Closed

Background

The United Nations Development Programme (UNDP) is the UN’s global development network, advocating for change and connecting countries to knowledge, experience and resources to help people build a better life, as envisaged by 2030 Agenda for Sustainable Development. We are on the ground in more than 170 countries and territories, working with governments and people on their own solutions to global and national development challenges to help empower lives and build resilient nations.

The Bureau for Policy and Programme Support (BPPS) has the responsibility for developing all relevant policy and guidance to support the results of UNDP’s 2018-2021 Strategic Plan and help countries to achieve the Sustainable Development Goals.

UNDP is a founding cosponsor of the Joint UN Programme on HIV/AIDS (UNAIDS), a partner of the Global Fund to Fight AIDS, TB and Malaria, and a co-sponsor of several other international health partnerships. UNDP’s work on HIV, health and development, as described in the HIV, Health and Development Strategy 2016-2021: Connecting the Dots, leverages UNDP’s core strengths and mandates in human development, governance and capacity development to complement the efforts of specialist health-focused UN agencies. UNDP delivers three types of support to countries in HIV, health and development.

First, UNDP helps countries to mainstream attention to HIV and health into action on gender, poverty and the broader effort to achieve and sustain the Sustainable Development Goals.

Second, UNDP works with partners to address the interactions between governance, human rights and health responses. Sometimes this is done through focused or specialized programmes, such as promoting attention to the role of the law and legal environments in facilitating stronger HIV responses, including the use of flexibilities in intellectual property law to lower the cost of medicines and diagnostics. UNDP also works to empower and include marginalized populations who are disproportionately affected by HIV, such as sex workers, men who have sex with men and people living with HIV. Beyond these focused efforts, UNDP plays a role in ensuring attention to HIV and health within broader governance and rights initiatives, including support to municipal action on SDGs, sustainable responses for Health and HIV such as improving sustainability of AIDS financing, sustainable health procurement, strengthening of national human rights institutions and increasing access to justice for key populations.

Third, as a trusted, long-term partner with extensive operational experience, UNDP supports countries in effective implementation of complex, multilateral and multi-sectoral health projects, while simultaneously investing in capacity development so that national and local partners can assume these responsibilities over time.

UNDP’s Partnership with the Global Fund

UNDP’s partnership with the Global Fund to Fight ADS, Tuberculosis and Malaria (Global Fund) is an important part of this work, facilitating access to resources for action on SDG 3 by countries that face constraints in directly receiving and managing such funding. UNDP partners with countries in crisis/post-crisis situations, those with weak institutional capacity or governance challenges, and countries under sanctions. When requested, UNDP acts as interim Principal Recipient in these settings, working with national partners and the Global Fund to improve management, implementation and oversight of Global Fund grants, while simultaneously developing national capacity to be able to assume the Principal Recipient role over time.

Health procurement and supply chain management support, an integral part of development solutions and support services that UNDP provides for the implementation of large and complex health programmes, contribute to the equitable delivery of essential services.

The national and international health landscapes are rapidly changing. New health initiatives are emerging, particularly in relation to non-communicable diseases, which bring to light pressing challenges linked to health systems strengthening including, health procurement and supply chain management. These opportunities go beyond UNDP’s partnership with the Global Fund and require a new modus operandi to optimize UNDP’s investments into global health. In addition, UNDP needs to continue to expand opportunities for partnerships with key stakeholders on health procurement including with UNICEF, UNFPA and UNOPS/Global Drug Facility but also on supporting the development of national supply chains with additional partners such as GAVI, WHO, and WFP.

UNDP’s Role in Provision of Health Products:

Generated out of the success of the UNDP-Global Fund partnership, a rapidly increasing number of governments are requesting UNDP to help strengthen national capacities and systems for the provision of health services, especially for the procurement and supply management of medicines and health products.

The primary focus of this procurement has been medicines and diagnostics for infectious diseases, but it also includes a broad range of laboratory and hospital equipment. Increasingly, UNDP is receiving requests to support the procurement of medicines, diagnostics and medical equipment for non-communicable diseases (NCDs). In addition to procurement services, UNDP also supports governments to build resilient health systems and support the national procurement and supply chain system. This includes providing technical expertise to strengthen legal, policy and regulatory frameworks, improve procurement rules and regulations, and remove potential barriers to equitable access to affordable medicines.

Conducting procurement of health products in a globalized pharmaceutical market places the organization at special risk of providing substandard products which could put patients’ health at risk, expose UNDP to legal actions, cause loss of money and severely damage the reputation of the organization. In line with established best practice, UNDP has a Quality Assurance (QA) Policy for all health products supplied by UNDP. The UNDP QA Policy is a key document for all parties involved in health procurement activities across UNDP as well as for national partners, suppliers and donors as it details UNDP’s requirements for health procurement, in line with international best practice. Consistent observance of this policy is essential to ensure UNDP health procurement is safe. Regular monitoring and oversight of the compliance of the QA policy, and support to its implementation, will be the responsibility of BPPS-HHD.

Under the direct supervision of the Senior Health Procurement and Supply Chain Management Advisor, Global Fund Health Implementation Support Team, HIV, Health and Development Group (GF/HIST), the Quality Assurance (QA) Specialist will be responsible for the development, implementation and monitoring of the UNDP QA Policy for health products. The Quality Assurance (QA) Specialist will provide QA oversight in UNDP projects particularly in the procurement and supply of health products such as pharmaceuticals, medical devices and diagnostics products and will work to ensure that health products procured and distributed within UNDP projects are compliant with the requirements of the UNDP QA Policy. The role will also require representing UNDP in international, regional forums for quality assurance of health products and the engagement with relevant partners on this topic.

Duties and Responsibilities

1) Provides technical support on Quality Assurance (QA) for the sourcing and monitoring of health products procured and supplied by UNDP with the following key responsibilities:

Provides technical support for the quality assessment of health products sources (manufacturers, products, procurement agencies);
Develops and updates the QA manual and any others related documents (including training documents) in collaboration with the relevant UNDP units;
Ensures that all QA activities are appropriately documented and develops and maintains a record management system;
Acts as the focal point for the annual QA performance review of the suppliers in coordination with UNDP’s Procurement Support Unit;
Coordinates the updating of UNDP database of qualified suppliers and health products;
Participates in the adjudication of tenders for health products for QA aspects;
Provides technical advice and guidance for the selection of quality control laboratories, particularly for establishing the scope of work, the methodology for testing and reporting;
Leads and coordinates the monitoring of the quality of the health products (quality testing reports, follow-up complaints, re-assessment of sources).

2) Provides advisory and technical support services to UNDP Country Offices (COs), Regional and Headquarters (HQ) staff on QA related issues, with the following key responsibilities:

Provides technical advice and guidance to the Procurement and Supply Chain Managements Specialists (HQ, Regional, COs) on technical issues related to the quality of health products and monitoring of suppliers for all QA aspects;
Advises on the improvement and establishment of QA processes, procedures taking into consideration the local conditions and ensuring they are in line with international good practices within UNDP projects;
Identifies QA issues, challenges and risks and provides constructive solutions in the handling of health products at country level (storage and distribution);
Ensures staff training at HQs, regional and CO levels and ensure the availability of training material and technical updates.

3) Ensures human resources management and supervision of QA team and experts and information sharing, with the following key responsibilities:

Builds and creates a positive team environment where team members are able to perform optimally, respond to challenges creatively and collaboratively, and access coaching and mentoring as needed;
Facilitates effective collaborative work planning and implementation processes for the implementation, monitoring and review of the QA Policy and the achievement of results within the resources allocated;
Coordinates recruitment processes with the Senior Health Procurement and Supply Chain
Management Advisor and performance management systems ensuring link of job design with recruitment, performance management and career development and establishes and maintains a roster of specialized consultants;
Contributes to internal reports and/or publish findings including the annual QA report on the implementation, compliance and monitoring of QA Policy.

4) Ensures collaboration and communication with QA experts from international, regional and local levels, with the following responsibilities:

Acts as the focal point for communications with WHO, other UN agencies, non-governmental agencies, the Global Fund and others key actors for all matters related to QA of heath products;
Represents UNDP in relevant technical meetings with partners, working groups and works towards harmonization and update of the QA Policy and other relevant QA matters (e.g. substandard/falsified health products);
Contributes substantially to information sharing on quality of sources and quality complaints with other agencies/partners at the global, regional and local level;
Actively participates in UNDP and other relevant external networks to promote the UNDP QA Policy and its implementation in relevant forums (conferences, e-forum).

Any other activity assigned by the Senior Health Procurement and Supply Chain Management Advisor, GF/HIST.

Competencies

Corporate competencies

Innovation:

Ability to make new and useful ideas work.

Leadership:

Ability to persuade others to follow

People Management:

Ability to improve performance and satisfaction

Communication:

Ability to listen, adapt, persuade and transform.

Delivery

Ability to get things done while exercising good judgement.

Technical/Functional

HIV, Health and Development Access to Treatment:

Knowledge of HIV/AIDS, tuberculosis and malaria and non-communicable diseases access to treatment policy and principles and strategic and/or practical situations

Quality Assurance:

Knowledge of and practical experience of issues related to QA of health products and the ability to apply them to strategic and/or practical situations relevant to procurement of health products.

Project Management:

Ability to plan, organize, and control resources, procedures and protocols to achieve specific goals.

Procurement Supply Management:

Knowledge of procurement and supply management concepts, principles and methods, and ability to apply to strategic and/or practical situations.

Risk Management:

Ability to identify and prioritize risks, and organize action around mitigating them.

Capacity Development :

Ability to strengthen and maintain the capabilities of individuals, societies, organizations and governments to set and achieve development objectives over time.

Knowledge Management:

Ability to capture, develop, share and effectively use information and knowledge.

Required Skills and Experience

Education:

Master’s degree or equivalent in Pharmacy. Additional Public Health diploma and/or Quality assurance in health products certification is an asset.

Experience:

A minimum of 7 years of relevant professional experience with the majority working in quality assurance for health products at national and international level including, developing quality assurance related policies, tools and providing guidance to procurement teams;
Demonstrated understanding of WHO prequalification program and/or others assessment/registration process followed by stringent regulatory authorities, with a knowledge or understanding of national regulatory requirements in low and middle countries;
Solid experience in the management of people and complex situations in high- pressure environments an asset;
Experience in developing partnerships with UN agencies, partners and donors on quality assurance issues for health products;
Excellent interpersonal, written and oral communications skills;
Experience in interacting with government officials and major supplier’s companies an asset.

Language Requirements:

Proficiency in English both written and oral.
Working knowledge of another UN language desirable.

Other:

Willingness to travel frequently including visits to UNDP suppliers and Country Offices.
Experience in the usage of computers and office software packages (MS Word, Excel, etc.) and advance knowledge of web-based management system.

Disclaimer

Important information for US Permanent Residents ('Green Card' holders)

Under US immigration law, acceptance of a staff position with UNDP, an international organization, may have significant implications for US Permanent Residents. UNDP advises applicants for all professional level posts that they must relinquish their US Permanent Resident status and accept a G-4 visa, or have submitted a valid application for US citizenship prior to commencement of employment.

UNDP is not in a position to provide advice or assistance on applying for US citizenship and therefore applicants are advised to seek the advice of competent immigration lawyers regarding any applications.

Applicant information about UNDP rosters

Note: UNDP reserves the right to select one or more candidates from this vacancy announcement. We may also retain applications and consider candidates applying to this post for other similar positions with UNDP at the same grade level and with similar job description, experience and educational requirements.

Workforce diversity

UNDP is committed to achieving diversity within its workforce, and encourages all qualified applicants, irrespective of gender, nationality, disabilities, sexual orientation, culture, religious and ethnic backgrounds to apply. All applications will be treated in the strictest confidence.

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