USP’s Global Health and Manufacturing Services (GHMS) department supports multiple countries in southeast Asia to build the capacity of their Medical Product National Quality Control Laboratories (NQCLs). In addition to strengthening the technical capacity of the NQCLs and implementing robust quality management systems, GHMS is working with relevant domestic and regional technical partners to develop long-term strategic plans for NQCLs.
Scope of Work
In Cambodia and Laos, the Australian Department of Foreign Affairs and Trade (DFAT) has contracted USP to strengthen the NQCLs in both countries towards achievement of ISO accreditation and WHO prequalification. In addition, USP will support the development laboratory strategic plans that covers the mission, vision, values, objectives, goals, resources, and KPIs that are needed to sustain a well-functioning NQCL. USP seeks a consultant/vendor whose responsibilities will be to review relevant documents, perform an environmental scan, and liaise with key local health partners to understand the local medicines regulatory landscape. He/she will lead the development of a long-term strategic plan that lays out a clear vision for the future of the NQCL’s and provides a roadmap to implement this vision. He/she will also provide guidance to the NQCLs to identify, where needed, relevant elements of a strategic plan.
The consultant/vendor will work within a dynamic, fast-paced environment. The consultant/ vendor will liaise with national counterparts, and GHMS staff and consultants to implement the activities, ensuring high-quality project deliverables in compliance with all USP and donor requirements.
The period of performance for this consultancy will begin August 1, 2022, and end May 30, 2023
Key Responsibilities
· Prepare a work plan for the development of the laboratory strategic plan
· Review relevant national and international guidelines and policy documents
· Conduct desk research into relevant health policies, laws, and regulations that impact NQCL
· Conduct data gathering exercise on NQCL revenue, revenue streams, throughput capacity, and other relevant data points
· Organise and facilitate interviews and workshop/s with relevant local health partners
· Perform an environmental scan, which will include at least a customer segmentation analysis and SWOT analysis
· Organise and facilitate workshop/s and interviews with NQCL to introduce the value of strategic plan, and identify the focus areas and strategic objectives of the strategic plan
· Draft and finalize a laboratory strategic plan, in close collaboration with the NQCL, which includes a monitoring and evaluation framework, key performance indicators, and an annual implementation plan
· Collaborate closely with USP GHMS staff and consultants in the implementation of activities
· USP may engage the consultant on different assignments, as needed.
Deliverables
· Workshop reports
· Strategic plan and related documents including:
o Environmental scan
o Monitoring and evaluation framework
o Annual implementation plan
Qualifications
· Minimum of five (5) years’ experience developing strategic plans for medicines regulatory authorities, national quality control laboratories, other laboratory networks, infectious disease area programs or related organizations
· Understanding of monitoring and evaluation frameworks and principles
· Fluent in written and spoken English
· Experience working in low- and middle-income countries in Southeast Asia is preferred
· Experience implementing strategic planning in a donor funded context preferred
Please send CV, 3-References, and Hourly Rate to ATTN: Hana Keno, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of August 26, 2022.
When submitting your application, write “National Quality Control Laboratory Strategic Plan Development consultants for Laos and Cambodia” in the email Subject Line.
Background
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.
