Product Quality Officer

UNOPS

UNOPS supports the successful implementation of its partners’ peacebuilding, humanitarian and development projects around the world. Our mission is to serve people in need by expanding the ability of the United Nations, governments and other partners to manage projects, infrastructure and procurement in a sustainable and efficient manner.

Working in some of the world’s most challenging environments, our vision is to advance sustainable implementation practices, always satisfying or surpassing our partners’ expectations.

With over 7,000 personnel spread across 80 countries, UNOPS offers its partners the logistical, technical and management knowledge they need, wherever they need it.

A flexible structure and global reach means that we can quickly respond to our partners' needs, while offering the benefits of economies of scale.

Stop TB Partnership

UNOPS hosts the Stop Tuberculosis Partnership Secretariat (STBP) as of 1 January 2015, in Geneva, Switzerland. The vision of the Stop TB Partnership is to realize the goal of elimination of Tuberculosis (TB) as a public health problem and, ultimately, to obtain a world free of TB by ensuring that every TB patient has access to effective diagnosis, treatment and cure; stopping transmission of TB; reducing the inequitable social and economic toll of TB; and developing and implementing new preventive, diagnostic and therapeutic tools and strategies. The Stop Partnership is uniquely positioned to support the development and further implementation by partners of the current and future Global Plan, acting as a coordinator and catalyst for the range of partners engaged in the fight against TB.

Founded in 2001, the Stop TB Partnership's mission is to serve every person who is vulnerable to TB and ensure that high-quality treatment is available to all who need it. Our partners include international and technical organizations, government programmes, research and funding agencies, foundations, NGOs, civil society and community groups and the private sector

As a key initiative of the STBP, the goal of the Global Drug Facility (GDF) is to facilitate world-wide, equitable access to TB medicines and diagnostics across both public and private sectors. This goal is achieved through management and coordination of market activities for the full portfolio of TB medicines and diagnostics, strategic procurement and innovative logistics solutions, technical assistance and capacity building for TB program in better pharmaceutical management practices, and accelerated uptake of new TB medicines, regimens, and diagnostics using the GDF “launch pad”.

The GDF procures all groups of medicines and key diagnostic tools that are currently recommended by WHO for diagnosis, prevention and treatment of drug susceptible and resistant forms of TB. When procuring through GDF, countries are ensured to receive quality-assured TB products in compliance with WHO Prequalification Program and Stringent National Medicines Regulatory Authorities or the Global Fund – ERP program.  

In addition, GDF applies a unique drug monitoring program coordinated with and performed by contracted Quality control agents which consists of the review of certificate of analysis for procured products, pre-shipment inspection of consignments, sampling and quality testing of products supplied to countries.

The Stop TB Partnership is hiring a Product Quality Officer who will work under the supervision of the Product Quality Lead to ensure that TB medicines and diagnostics procured and supplied by GDF to countries are quality assured and of adequate standard.

The Product Quality Officer will be responsible of the following activities:

a)     S/he improves the GDF product quality and regulatory related tools, systems and processes:

-       Identify QA issues, challenges and risks, and propose innovative solutions and optimal risk-mitigation measures

-       Develop and maintain excel/access tool that tracks the availability of valid regulatory and quality documents for importation of TB medicines and diagnostics, as per the National Regulatory Authorities requirements

-       Create a dashboard for rapid tracking and review of product quality and regulatory documents

-       Maintain and improve the standardized excel/access tool for systematic review of product Certificate of Analysis (CoA) vs approved pharmacopeia monographs; provide brief analysis of the currently available results;

-       Enhance TB medicines and diagnostics quality complaints management and its recording and reporting tool.

-       Contribute to analytical work on the effectiveness and impact of GDF QA policy for TB medicines and diagnostics from a product and access perspective

-       Ensure availability of QA training, technical updates, and best practices sharing sessions

b)    S/he stands as GDF QA responsible person for diagnostics:

-       Review and update the GDF QA policy for diagnostics

-       Establish the GDF quality monitoring program for diagnostics

-       Manage and monitor the operationalization and implementation of the QA policy and quality monitoring program for diagnostics, including quality testing requirements, selection of quality control agents/laboratories

-       Monitor QA status progress for WHO recommended diagnostics

-       Act as the quality focal point for GDF diagnostic tenders

-       Act as focal point for managing diagnostic quality complaints

-       Work in close collaboration with partners, including normative agencies such as WHO and regulatory authorities, technical partners and manufacturers.

-       Work with partners toward harmonization of QA policy for diagnostics and approaches to respond to countries program needs for access to quality-assured diagnostics

c)     Assist with developing the GDF online TB products catalogue.

d)    Review and maintain up to date the GDF list of quality assurance and quality control (QA/QC) activities and achievements on the Stop TB /GDF webpage.
e)    Perform other related responsibilities as assigned by GDF Product Quality Lead.

Quarterly reporting on activities and deliverables to GDF Product Quality Lead for performance monitoring.

• Advanced university degree (master's or equivalent) in pharmacy, medicine or public health. 

• A minimum of 5 years of professional experience working in quality assurance for Health Products (in particular for pharmaceutical products and/or diagnostic products) including in quality control, at national and international level
• Experience working in international organizations, such as UN agencies, donors or technical agencies, NGOs and/or private sector companies
• Experience in developing partnerships with UN agencies, international NGOs and donors on QA issues
• Experience in developing QA related policies, tools and guidance for diagnostics
• Experience in Public Health/Procurement and Supply Chain Management (PSM) of Health Products
• Experience in managing complex situations, issues at country, regional and international level
• Experience in working in the TB environment, TB medicine or diagnostic management

• Quality assurance and quality control diploma, especially for diagnostics, is an asset.

• English and French are the working languages of the United Nations Secretariat. For this post, fluency in English is required and good working knowledge of French preferably.
• Working knowledge of other UN official languages is desirable.

• Understanding of QA matters in the pharmaceutical manufacturing context and for diagnostics
• Understanding of WHO pre-qualification procedures of medicines and diagnostics and the assessment/ registration procedures followed by stringent regulatory authorities, knowledge or understanding of national regulatory requirements and processes in low and middle income countries
• Understanding of the influence of national and global health policy issues (in particular those related to QA) on procurement and supply of pharmaceuticals and diagnostics
• Knowledge of pharmaceutical procurement and supply chain good practices
• Take the lead in solving complex issues.
• Analytical thinking with ability to draw on complex data sources to provide strategic recommendations.
• Adapt policy and guidance to the reality / context.
• Excellent communication, planning and organizational skills, attention to detail, ability to multi-task, ability to work effectively under pressure and meet deadlines
• Cultural sensitivity and integrity.

• Please note that the closing date is midnight Copenhagen time
• Applications received after the closing date will not be considered.
• Only those candidates that are short-listed for interviews will be notified.
• Qualified female candidates are strongly encouraged to apply.
• For staff positions only, UNOPS reserves the right to appoint a candidate at a lower level than the advertised level of the post
• The incumbent is responsible to abide by security policies, administrative instructions, plans and procedures of the UN Security Management System and that of UNOPS.  

It is the policy of UNOPS to conduct background checks on all potential recruits/interns.
Recruitment/internship in UNOPS is contingent on the results of such checks.