Product Quality Assurance Consultant (Roster)

The UNOPS Global Portfolios Office (GPO) brings together diverse expertise to help partners deliver impact worldwide. With hubs in New York, Geneva, and Vienna, and expert teams operating globally, GPO leads multi-regional initiatives that advance sustainable development, climate action, and peacebuilding - including in some of the world’s most challenging environments. By leveraging our collective expertise and global networks, GPO supports UNOPS’ strategic priorities and the Sustainable Development Goals across more than 130 countries. We work closely with major global partners - including governments, international financial institutions, and UN agencies - to deliver a wide range of services, such as project management, fund management, hosting services, and HR support.

As part of the Global Portfolios Office, UNOPS Geneva provides comprehensive solutions in secretariat hosting, operational support, and fund management. We manage global programmes, including the Water, Environment and Climate (WEC) Portfolio, offering project management, procurement, HR, and financial services. Geneva hosts the secretariats of eight global partnerships focused on health (RBM, Stop TB, ATscale), nutrition (SUN), water/sanitation (SHF), humanitarian leadership (GELI), urban development (Cities Alliance), and disaster displacement (PDD). We also provide fund management for EIF and UN Water, and operational support to Geneva-based partners like the Global Fund and UNHCR. The EU-UNOPS Lives in Dignity (LiD) Grant Facility is also based here.

As part of the Global Portfolio Office, UNOPS Geneva provides comprehensive solutions in secretariat hosting, operational support, and fund management. We manage global programmes, including the Water, Environment and Climate (WEC) Portfolio, offering project management, procurement, HR, and financial services. Geneva hosts the secretariats of eight global partnerships focused on health (RBM, Stop TB, ATscale), nutrition (SUN), water/sanitation (SHF), humanitarian leadership (GELI), urban development (Cities Alliance), and disaster displacement (PDD). We also provide fund management for EIF and UN Water, and operational support to Geneva-based partners like the Global Fund and UNHCR. The EU-UNOPS Lives in Dignity (LiD) Grant Facility is also based here.

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

• Provide technical advice to GDF management on  quality assurance risks, regulatory compliance trends and related issues

• 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.

Required

• A Master’s degree in pharmaceutical sciences, or biomedical engineering, or biological sciences, or  a related field  is required.

• A bachelor's with an additional 2 years of experience may be considered in lieu of a master’s degree.

Required

• At least 5 years of experience in Quality Assurance for medical devices and/or other health products is required

• Experience in in-vitro diagnostics and in applying relevant regulatory frameworks, including but not limited to IMDRF, WHO Prequalification, EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, or equivalent standards, is required

• Proven track record evaluating products' QA submissions from manufacturers' dossiers is an asset.

• Experience in Compliance with Good Manufacturing Practices requirements for suppliers and manufacturers is an asset.

• Experience collaborating remotely with multicultural teams is an asset.

• Understanding of ISO 13485, ISO 14971, ISO 9001, MQAS and QMS audits for medical devices is an asset.

• Please note that UNOPS does not accept unsolicited resumes. 
• Please note that UNOPS will at no stage of the recruitment process request candidates to make payments of any kind.
• Applications to vacancies must be received before midnight Copenhagen time (CET) on the closing date of the announcement. Applications received after the closing date will not be considered. 
• Please note that only shortlisted candidates will be contacted and advance to the next stage of the selection process, which involves various assessments. 
• UNOPS embraces diversity and is committed to equal employment opportunity. Our workforce consists of many diverse nationalities, cultures, languages, races, gender identities, sexual orientations, and abilities. UNOPS seeks to sustain and strengthen this diversity to ensure equal opportunities as well as an inclusive working environment for its entire workforce. 
• UNOPS evaluates all applications based on the skills, qualifications and experience requirements outlined in the vacancy announcement. We are committed to considering all candidates in a fair and transparent manner, and we value diverse perspectives and experiences, including those of women, indigenous and racialized communities, individuals with diverse gender identities and sexual orientations, and people with disabilities.
• We would like to ensure all candidates perform at their best during the assessment process. If you are shortlisted and require additional assistance to complete any assessment, including reasonable accommodation, please inform our human resources team when you receive an invitation.

• 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 (they take around 4 hours to complete) in your own time, before providing services to UNOPS. Refreshers or new mandatory courses may be required during your contract. Please note that you will not receive any compensation for taking courses and refreshers. For more information on a retainer contract here. 
• For more details about the contract types, please click here.
• All UNOPS personnel are responsible for performing their duties in accordance with the UN Charter and 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 personnel. Recruitment in UNOPS is contingent on the results of such checks.