Stop TB Partnership – Quality Product Officer

Background Information – Job-specific

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. Stop TB partners include international and technical organizations, government programme, research and funding agencies, foundations, NGOs, civil society and community groups and the private sector. The Stop TB Partnership is hosted by the United Nations Office for Project Services (UNOPS) in Geneva, Switzerland.

As a key initiative of the Stop TB Partnership, the objective of the Global Drug Facility (GDF), an ISO:9001:2015 certified entity, is to ensure access to quality-assured TB drugs, diagnostics, and other health products by employing innovative business approaches, efficient knowledge management for factual leadership in market management, strategic procurement, and high-quality procurement and supply services to client countries. GDF’s strategic vision of success is that all people requiring TB diagnostics and medicines can access them from markets optimized to meet public health needs.

The GDF procures all groups of medicines, key diagnostic tools and other health products 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 or Stringent National Medicines Regulatory Authorities or the Global Fund – ERP program.

In addition, GDF applies an outstanding Drug Monitoring Program (DMP) coordinated with and performed by contracted Quality control agents which consists of the review of the manufacturer issued certificate of analysis for procured product batches, consignment pre-shipment inspection and sampling, and quality testing of product batches supplied to countries.

The Product Quality Officer will be part of the Strategic Procurement and Business Intelligence (SPBI) unit that aims to ensure timely access to quality-assured TB products appropriately adapted, affordable and sustainably priced. She/He will work under the supervision of the Lead Product Quality Officer and in close collaboration with other GDF teams and partners, to ensure that TB medicines, diagnostics and other health products procured and supplied by GDF to countries are quality assured and of adequate standard.

All activities performed by the Product Quality Officer will be implemented in accordance with the ISO9001:2015 GDF quality manual.

Work for this position calls for excellent technical and writing skills.

Functional Responsibilities

The Product Quality Officer will act as the GDF focal point for quality of diagnostics and other health products and will be responsible to perform the functions/tasks described below and deliver results, under the supervision of the Lead Product Quality Officer

The main responsibilities include:

Ensure the quality of TB diagnostics and other health products such as medical devices, medical software, digital adherence tools procured and supplied to GDF client countries for the diagnosis, prevention, and treatment of drug susceptible and resistant forms of TB.

• Review and update the GDF QA policy for diagnostics and other health products in compliance with applicable high-quality standards.

• Develop the GDF quality monitoring program for diagnostics and other health products (DHMP) including pre-shipment inspection of consignments, sampling, and quality testing.

• Contribute to the tender for selection of the quality control agents (QCAs) responsible for performing the activities related to DHMP and support contract management of QCAs.

• Develop SOP and critical metrics to implement and supervise the efficiency of GDF’s QA policy and quality monitoring program for diagnostics and other health products, and identify/implement corrective and improvement actions where needed.

• Work in close collaboration with manufactures and the regulatory and standardization agencies and authorities including WHO to assure quality status of diagnostics and other health products.

• Maintain up to date list of eligible and quality assured diagnostics and other health products for GDF procurement.

• Handle quality complaints for diagnostics and other health products.

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

Support the development of GDF’s systems and processes for handling and supervising quality of TB products procured and supplied to countries.

• Coordinate and support the development of the GDF web-based platform tool for efficient management and monitoring of QA status of TB products, their registration status in countries, quality product complaints and related supportive documentation GS1 standards

• Work in close collaboration with GDF’s contracted procurement agent and other relevant partners for the implementation of the GS1 Standards for TB products. Environmental sustainability

• Work with relevant partners and manufacturers for the development of the GDF’s environmental sustainability strategy that GDF will use in its strategic procurement to encourage environmentally sustainable and driven markets whilst ensuring uninterrupted access to TB products.

Document GDF results and incorporate lessons learned into new approaches (The below sub-activities are indicative)

• Report on the efficiency and impact of GDF QA policy for TB products from a product, access, and cost perspective

• Develop relevant indicators, dashboards, and infographics to monitor, evaluate, present and document GDF QA results and achievements against targets.

• Draft reports, briefs, presentations for Board and donors

• Identify key conferences where GDF can disseminate GDF QA achievements and coordinate sessions, symposia, satellites, in collaboration with key stakeholders Perform other duties as requested

• The Quality Product Officer will undertake other special work related to general activities within the StopTB partnership’s Global Drug Facility, assigned and determined by Stop TB’s Executive director, GDF Chief, SPBI Manager or Lead Product Quality Officer. Impact of Results

• TB products including TB diagnostics and other health products procured and supplied by GDF to countries are quality-assured.

• GDF QA’s policy and quality monitoring program for diagnostics and other health products are in force.

• Bar coding is in place to ensure batch traceability for TB products procured by and supplied to countries by GDF.

• GDF environmental sustainability strategy is integrated in GDF strategic procurement processes and procedures.

Education/Experience/Language requirements

Education

• Advanced university degree (master’s or equivalent) in pharmacy, medicine, biology, public health, or other field related to the job description.

• A University Degree (Bachelor degree or Undergraduate) with additional two (2) years of experience will be considered in lieu of an advanced University Degree.

• Quality assurance and quality control diplomas, especially for diagnostics and/or medical devices is an asset.

Experience Requirements:**

A minimum of five (5) years of professional experience working in quality assurance ideally for Health Products (pharmaceuticals, and/or diagnostics and/or medical devices) including in quality control, at national and/or international level.

Highly desired experience:

• Experience in developing QA policies, tools, and guidance for diagnostics and/or medical devices.

• Experience in developing partnerships with UN agencies, international NGOs, and donors on QA issues.

• Experience in Public Health/Procurement and Supply Chain Management (PSM) of Health Products.

• Good writing skills.

Desired experience:

• Experience in managing complex situations, issues at country, regional and international level.
• Experience in TB medicine and/or diagnostics and/or medical devices management.

Language

• Fluency in English is essential,
• Fluency in written and spoken French is a strong asset for this selection process.

Contract type, level and durationContract type:** UN Staff – Temporary Appointment.

Contract level: ICS10 – P3 equivalent.
Contract duration: Appointment with UNOPS will be valid until 31st December 2021. Possibility to extend under the new host of STBP in 2022.