Product Quality Officer

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 acquire 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, STBP'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 programmes, research and funding agencies, foundations, NGOs, civil society 
and community groups and the private sector.

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, medical devices, 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 ISO 9001:2015 and the GDF quality manual.

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

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

• Review and update the GDF QA policy for diagnostics and other health products in compliance with applicable international 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 monitor 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 manufacturers 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
• Contribute to the tender evaluation for selection of the suppliers for the procurement of medical devices, diagnostics and other health products.

• 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

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

• 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.

• 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

• 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.

• 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.

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

• A minimum of five (5) years of professional experience working in quality assurance and/or quality control preferably for Health Products (e.g. pharmaceuticals, and/or diagnostics and/or medical devices), at national and/or international level is required. 

• Experience in developing QA policies, tools, and guidance for TB diagnostics and/or medical devices
• Experience in developing partnerships with UN agencies, international NGOs, and donors on QA issues related to TB medicines and medical devices
• Experience in Public Health/Procurement and Supply Chain Management (PSM) of Health Products
• Experience in regulation of TB medicines/ diagnostics/ medical devices and related products
• Good writing skills
• Experience in managing complex situations, issues at country, regional and international level
• Experience in TB medicine and/or diagnostics and/or medical devices management

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

Contract type: Fixed-term staff contract Contract level: P-3
Contract duration: One year initially, renewable subject to satisfactory performance and funding availability

• 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.
• UNOPS embraces diversity and it is committed to the principle of equal employment opportunity for all its employees and encourages qualified candidates to apply irrespective of race, colour, national origin, ethnic or social background, genetic information, gender, gender identity and/or expression, sexual orientation, religion or belief, or disability.
• UNOPS seeks to reasonably accommodate candidates with special needs, upon request.
• Work life harmonization - UNOPS values its people and recognizes the importance of balancing professional and personal demands. We have a progressive policy on work-life harmonization and offer several flexible working options. This policy applies to UNOPS personnel on all contract types
• This position is based in a family duty station
• For staff positions only, UNOPS reserves the right to appoint a candidate at a lower level than the advertised level of the post
• For retainer contracts, you must complete a few Mandatory Courses (around 4 hours) in your own time, before providing services to UNOPS.
• The incumbent is responsible to abide by security policies, administrative instructions, plans and procedures of the UN Security Management System and that of UNOPS.  
• All UNOPS personnel are responsible for performing their duties in accordance with the UN Charter, UN Staff Regulations and Rules, UNOPS Policies and Instructions, as well as other relevant accountability frameworks. In addition, all personnel must demonstrate an understanding of the Sustainable Development Goals (SDGs) in a manner consistent with UN core values and the UN Common Agenda.
• 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.

UNOPS – an operational arm of the United Nations – supports the achievement of the Sustainable Development Goals (SDGs) by successfully implementing its partners’ peacebuilding, humanitarian, and development projects around the world. Our mission is to help people build better lives and countries achieve peace and sustainable development.
UNOPS areas of expertise cover infrastructure, procurement, project management, financial management, and human resources.


Working with us
We are proud of our people. With a wealth of knowledge and skills in various disciplines – engineering, finance, human resources, ICT, leadership, project management, procurement, and more – they help tackle some of the biggest challenges of our time. Their work around the world supports progress toward the Sustainable Development Goals (SDGs).


At UNOPS, we offer a range of short- and long-term opportunities in various environments and duty stations – from Denmark and Kenya to Mexico, Switzerland, Myanmar, Senegal, Uganda, and many more.


Diversity
With over 5,000 UNOPS personnel and approximately 7,400 personnel recruited on behalf of our partners, spread across 80 countries, our workforce represents a range of nationalities and cultures. We promote a balanced and diverse labor force — a strength that helps us better understand and address our partners’ needs. We continually strive to maintain our gender-balanced workplace. We encourage qualified underrepresented groups as per UNOPS Gender, Diversity, and Inclusion Strategy to apply for our vacancies.



Work life harmonization
UNOPS values its people and recognizes the importance of balancing professional and personal demands.

Based in Geneva, the Europe and Central Asia Regional Office (ECR) supports UNOPS offices throughout the region through: management, financial and programmatic oversight of global and country-specific portfolios, clusters and operations centres, including hosting services; fund and management advisory services; project implementation; procuring goods and services; and managing human resources.

ECR ensures that projects are executed to the highest standards, providing a shared knowledge base and ensuring that best practices and lessons learned are disseminated between business units and projects across the entire region.

 ECR strategy is to:

• Strengthen UNOPS role in operationalizing the Sustainable Development Goals with particular emphasis on health, environment and economic development.
• Position UNOPS in the Balkan sub-region, the Caucasus and Central Asia.
• Strengthen the implementation of ECR global and regional programmes, with revitalized partnerships in infrastructure, procurement and project management.

ECR operates global portfolios from offices in Geneva, Brussels and New York, and country-specific programmes from its operations and project centres located in Eastern Europe and Central Asian countries.