About UNOPS
UNOPS is an operational arm of the United Nations, supporting the successful implementation of its partners’ peacebuilding, humanitarian and development projects around the world. Our mission is to help people build better lives and countries achieve sustainable development. UNOPS areas of expertise cover infrastructure, procurement, project management, financial management and human Resources.
UNOPS Global Portfolios bring together a range of expertise to help partners deliver impact worldwide. With hubs in New York, Geneva and Vienna, and expert teams operating across regions, we lead complex, multi-regional initiatives that advance sustainable development, peacebuilding and climate action. We work in close collaboration with the UN family, governments and other local and international partners. Our work ranges from supporting mine action in some of the world’s most fragile and conflict-affected contexts, to expanding access to healthcare and clean water, to helping protect the environment.
From Geneva, UNOPS strives to facilitate the achievement of the 2030 Agenda and the Sustainable Development Goals (SDGs), by working with governments, other United Nations (UN) agencies and partners. This includes supporting platforms and hosting high-profile, flagship initiatives and funds focusing on health, nutrition, water and sanitation, sustainable cities, environment, and trade. UNOPS is a recognized resource for the UN system in Geneva – from fund management and oversight and advisory services, to providing hosting solutions to a range of global initiatives, as well as operational support to partner organizations. UNOPS provides quality services, integrated solutions and management support to UN agencies, initiatives and partners in a strategic, cohesive, cost-effective and results-oriented manner. Geneva is also home to UNOPS Europe and Central Asia Regional Office.
About the Country/Multi-Country Office
The Stop TB Partnership’s Global Drug Facility (GDF), hosted by UNOPS, is a global mechanism that facilitates access to quality-assured, affordable tuberculosis (TB) diagnostics and treatments for low- and middle-income countries. Its Diagnostics Catalogue features a wide range of TB testing tools, sourced through competitive tenders from vetted manufacturers.
To maintain high standards and regulatory compliance, GDF conducts thorough technical and quality assessments of all submissions. These quality assurance (QA) reviews ensure that all products meet the requirements of the GDF QA Policy.
This is a fully remote position. All work, including document reviews, meetings, clarifications, and reporting, will be done virtually. Under the overall supervision and guidance of the Lead Product Quality Officer, the consultant will provide expert QA evaluations of manufacturer and supplier submissions, helping GDF make informed decisions about which products to include in its Diagnostics Catalogue. The main goals of the consultant will be to
Evaluate the completeness, quality, and compliance of suppliers’ dossier submissions.
Identify and flag any gaps, risks, or missing information.
Recommend whether to accept, request further information, or reject a submission.
Clearly document all evaluations to support transparent decision-making.
Job Specific Context
To ensure that diagnostic products included in the GDF Diagnostics Catalogue meet high standards of quality, safety, and regulatory compliance, GDF conducts structured technical and quality assurance (QA) assessments of all manufacturer and supplier submissions.
GDF is seeking a qualified Product Quality Assurance Consultant to support this process by performing independent, expert reviews of product dossiers submitted during tender rounds. The consultant will work fully remotely and will contribute to transparent, evidence-based decision-making by evaluating the completeness, accuracy, and regulatory compliance of submitted documentation in line with the GDF QA Policy.
Working under the overall guidance of the Lead Product Quality Officer and the direct supervision of the Product Quality Officer, the consultant will play a critical role in identifying risks, gaps, or non-compliance in supplier submissions and ensuring that only products meeting GDF’s quality requirements are recommended for inclusion in the catalogue.
The purpose of the product Quality Assurance Consultant role is to provide in-depth independent technical QA evaluations of manufacturer and supplier dossier submissions to support GDF’s product selection and procurement decisions.
The consultant will assess whether submitted dossiers are complete, accurate, and compliant with GDF’s QA Policy and applicable regulatory standards. By systematically reviewing QA and regulatory documentation, validating certifications, and clearly documenting findings and recommendations the consultant will help GDF identify potential risks, request clarifications where necessary, and determine whether products should be accepted, conditionally accepted pending further information, or rejected.
Through provision of technical advice, rigorous analysis, clear reporting, and ensuring strict adherence to data security and confidentiality requirements, the consultant will strengthen GDF’s quality assurance processes and support the inclusion of reliable, high-quality diagnostic products in the GDF Diagnostics Catalogue
In depth technical review of submitted QA documentation per product based on the GDF QA Policy.
Check and verify the manufacturer’s QA and regulatory documents for compliance.
Validate the authenticity and validity of ISO 13485/9001 or equivalent and other relevant certifications. Perform necessary technical due diligence on certifications and verification of accreditation status, including assessment of risks and implications
Confirm that certificates were issued by accredited notified bodies and are still valid.
Draft and submit questions for clarification as needed.
Assess any additional evidence submitted in response.
Prepare comprehensive QA evaluation reports for each product reviewed, including risk assessments and formal recommendations.
Provide technical advice to GDF management on quality assurance risks, regulatory compliance trends and related issues, as may be required
Data Security: Submissions may contain sensitive or proprietary information requiring the consultant to comply with GDF’s data handling and confidentiality policies.
The consultant is expected to deliver timely, high-quality technically sound QA evaluation reports for each assigned product submission, clearly documenting compliance with the GDF QA Policy, identified gaps or risks, and professional recommendations to accept, request additional information, or reject submissions. Outputs will also include professional technical reports, well-structured clarification questions, assessments of follow-up evidence provided by suppliers, and accurate verification of the validity and authenticity of quality management system certifications. All outputs must be completed in accordance with GDF timelines, documentation standards, and data security and confidentiality requirements.
