Lydia Nanyanzi

Global Leader in Quality Assurance, Regulatory Compliance & Technology Transfer I specialize in Quality Assurance, Regulatory Compliance, and Technology Transfer for medical device manufacturing, ensuring compliance with ISO 13485, cGMP, and global regulations. With expertise in Risk Management (ISO 14971), CAPAs, Root Cause Analysis, and Continuous Improvement, I drive operational excellence in Rapid Diagnostic Test (RDT) manufacturing and global technology transfers. 🔹 Key Achievements & Global Expertise: ✅ RDT Manufacturing Leadership: Led the establishment for the QMS of MHS's state-of-the-art RDT manufacturing plant for HIV, Malaria, Sickle Cell diagnostics and currently expanding for more products. ✅ Technology Transfer Management: Led the successful technology transfer between Microhaem Scientifics and WONDFO, ensuring seamless process integration for large-scale production. ✅ Regulatory & Certification Success: Spearheaded regulatory audits for NDA, securing cGMP certification and ISO 13485:2026 from TÜV. ✅ International Training & Certifications: WONDFO Biotech (China): ISO 13485:2016, QMS & Regulatory Compliance. WHO Training (Rwanda): RDT Manufacturing & QMS. ALISON Certifications: ISO 13485 & Risk Management (ISO 14971). UNBS : QMS 9001:2015 and Internal Audit Certificates ISL (UK): Internal Audit ✅ QMS Implementation & Compliance: Extensive experience in Gap Analysis, Implementation, and Continuous Improvement of end-to-end QMS. ✅ Trainer & Mentor: Conducted trainings on Risk Management, CAPAs, Data Integrity, Deviations, Document Control, Vendor Qualifications, Internal Audits, and Management Reviews. 🌍 Driving Quality & Compliance on a Global Scale Passionate about advancing medical device quality and regulatory compliance worldwide, I am open to strategic leadership roles in Quality Assurance, Regulatory Affairs, and Risk Management. 📩 Let’s connect to explore opportunities to enhance medical device quality and innovation globally!

As Country Director at MHS Rwanda, I led strategic business operations, driving growth, operational efficiency, and regulatory compliance. I oversaw multi-departmental functions, including procurement, logistics, quality assurance, finance, and client relations, ensuring seamless operations and business expansion. Key Achievements: ✔️ Established a Quality Management System (QMS) to enhance efficiency and regulatory adherence. ✔️ Attained ISO 9001:2015 certification, strengthening quality standards and compliance. ✔️ Successfully set up medical logistics warehousing and distribution, ensuring on-time execution. ✔️ Implemented real-time online monitoring of cold chain products, improving product safety and compliance. ✔️ Spearheaded Public-Private Partnership (PPP) contracts between MHS and ABBOTT Diagnostics & Molecular Division using IMS systems to streamline operations. Key Responsibilities: 🔹 Designed and implemented strategic business plans, optimizing efficiency and profitability. 🔹 Led cross-functional teams, overseeing procurement, logistics, quality, IT, finance, and sales. 🔹 Managed organizational budgets, cost optimization, and financial planning. 🔹 Ensured successful audits and regulatory compliance, leading CAPA initiatives. 🔹 Oversaw tender management, contract execution, and supplier/vendor relations. 🔹 Advised the MD and Board of Directors on operational and strategic decisions. This experience strengthened my expertise in strategic leadership, quality management, supply chain logistics, regulatory compliance, and stakeholder engagement—key pillars I continue to build upon in my current role.

In this role, I led the establishment of HR, administrative, and quality management systems, ensuring seamless operations across multiple locations. I played a key role in organizational development, policy formulation, and workforce management, contributing to the company’s long-term growth. Key Achievements: ✔️ Built HR departments from the ground up for both Uganda and Rwanda offices, setting the foundation for strong workforce management. ✔️ Developed HR and Admin manuals and policies, ensuring compliance, efficiency, and streamlined operations. ✔️ Established QMS departments that successfully supported the medical logistics division, enhancing compliance and operational excellence. ✔️ Managed a team of approximately 77 staff, overseeing recruitment, performance management, and professional development. ✔️ Implemented structured HR processes, including employee onboarding, training programs, and performance evaluation systems. ✔️ Strengthened administrative functions, improving organizational efficiency and internal controls. This experience solidified my expertise in HR leadership, organizational development, quality management, and administrative excellence, which I leveraged in my later roles to drive company-wide success.

-Sourcing and Liaising with Contractors and following up on the services provided, soliciting for Quotations and proposals and ensuring that contracts are honored. Ensuring that we source for quality and cost effective contractors and payment of contracts on time through following up with Job Completion Forms, Purchasing Orders and Invoices. -Handling Human Resource and welfare statuses for outsourced employees in my Accounts of jurisdiction. From Recruitment, performance appraisal, training and contract renewals. --Ensuring proper functionality of office equipment through regular servicing, replacements. Liaising with service providers and suppliers, handling their contracts, deadlines and ensuring smooth flow of operations in the work environment. --Maintaining a clean, healthy, safe and secure work environment while working hand in hand with cleaning companies, construction and renovators, Security Companies and Safety Management. --Interface between subcontracted staff and People Performance Group; responsible for relaying information, complaints and other related communication between both parties. --Assist the Administration Managers with any additional assigned duties. Substitute for Office Manager in cases when He/she is unavailable. -- Ensuring the safety of Information and maintaining privacy and confidentiality --Coordinate all aspects of expatriate staff including hotel bookings, transportation requests, and letters of invitation, official letters and embassy involvement as required. Proof reading Documents before they are signed and or sent out. --In charge of ordering and control of stock and issuance of stationery items to staff .Responsible for budgeting and accounting of petty cash for the office.

Sales and Marketing, Client Relations, Negotiation. --Closing sales by overcoming objections; asking for sales; negotiating price; completing sales or purchase contracts; explaining provisions; explaining and offering warranties, services, and financing; collects payment; delivers automobile --Providing sales management information by completing reports. --Developing buyers by maintaining rapport with previous customers; suggesting trade-ins; meeting prospects at community activities; greeting drop-ins; responding to inquiries; recommending sales campaigns and promotions. --Organizing and Chairing meetings,compiling minutes, handling client emails, inquiries and queries. General Office administration.