Product Quality Assurance Consultant

Product Quality Assurance Consultant (Retainer)

UNOPS is seeking a Product Quality Assurance Consultant with a specialized focus on ensuring global access to high-quality, ISO and GMP compliant diagnostic products. This fully remote, retainer contract offers flexible, high-impact support for rigorous, tender-based evaluations, maintaining high standards of transparency and quality within global health systems.

About the Global Portfolio Office (GPO)

The UNOPS Geneva Global Portfolio Office provides comprehensive solutions in secretariat hosting, operational support, and fund management. We manage global programs, including the Water, Environment and Climate (WEC) Portfolio, offering project management, procurement, HR, and financial services. Geneva hosts secretariats for eight global partnerships focused on health, nutrition, water/sanitation, humanitarian leadership, urban development, and disaster displacement. We also provide fund management and operational support to Geneva-based partners.

Role Purpose

The Product Quality Assurance Consultant will 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 dossier completeness, accuracy, and compliance with GDF’s QA Policy and applicable regulatory standards. By systematically reviewing documentation, validating certifications, and documenting findings, the consultant will help GDF identify risks, request clarifications, and make informed product acceptance decisions.

Functions / Key Results Expected

• Conduct in-depth technical review of submitted QA documentation per product based on the GDF QA Policy.
• Check and verify manufacturer’s QA and regulatory documents for compliance.
• Validate the authenticity and validity of ISO 13485/9001 or equivalent certifications.
• Perform technical due diligence on certifications, verifying accreditation status and assessing risks.
• Confirm that certificates were issued by accredited notified bodies and are still valid.
• Draft and submit questions for clarification as needed and assess any additional evidence provided.
• Prepare comprehensive QA evaluation reports for each product, including risk assessments and recommendations.
• Provide technical advice to GDF management on quality assurance risks and regulatory compliance trends.
• Ensure strict adherence to data security and confidentiality policies.

Data Security

Submissions may contain sensitive or proprietary information. The consultant must comply with GDF’s data handling and confidentiality policies.

Deliverables

The consultant is expected to deliver timely, high-quality, technically sound QA evaluation reports for each assigned product submission. Outputs will include compliance documentation, identified gaps or risks, recommendations for acceptance, requests for additional information, or rejection of submissions. Professional technical reports, clarification questions, assessments of follow-up evidence, and verification of quality management system certifications are also required, all in accordance with GDF timelines and standards.

Education Requirements

• A Master’s degree in pharmaceutical sciences, biomedical engineering, biological sciences, or a related field is required.
• A bachelor's degree with an additional 2 years of relevant experience may be considered in lieu of a master’s degree.

Experience Requirements

• At least 5 years of experience in Quality Assurance for medical devices and/or other health products.
• Experience in in-vitro diagnostics and applying relevant regulatory frameworks (IMDRF, WHO Prequalification, EU MDR/IVDR, FDA 21 CFR Part 820, or equivalent) is required.
• Proven track record evaluating products' QA submissions from manufacturers' dossiers is an asset.
• Experience in Compliance with Good Manufacturing Practices (GMP) 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.

Key Skills/Competency

• Quality Assurance
• ISO 13485
• GMP Compliance
• Regulatory Affairs
• Medical Devices
• Diagnostic Products
• Dossier Evaluation
• Risk Assessment
• Technical Review
• Pharmaceutical Sciences