USP will build on its proven approach and previous experiences working with the Government of Cambodia and the National Health Quality Control (NHQC) Laboratory to better safeguard the public from poor quality medical products. The Technical Assistance to Strengthen Cambodia’s Medicines Quality Assurance System program, funded by Global Fund, aims to support the NHQC to expand its existing ISO 17025 scope of accreditation for the Physico-Chemical (PC) Laboratory; prepare the PC laboratory for WHO prequalification; and prepare the Microbiology (MB) Laboratory for ISO 17025 accreditation. In this project, USP will not only provide assistance to NHQC on the scope expansion of ISO 17025 accreditation but also support NHQC in establishing the policy on the use of quality-assured vaccine in Cambodia, including vaccine lot release.
USP is seeking a Vaccine Expert to provide assistance in the development the legal and regulatory framework around vaccine lot release, specifically in establishing a vaccine lot release system based on reliance on or recognition of other NRAs’ Lot Release for the use of WHO Pre-Qualified vaccine,
and in conducting summary lot protocol review based on lot release activity for non-PQ-ed vaccines. The Vaccine Expert will report directly to the Technical Lead.
Thisconsultancy has a period of performance from October - December 2025.
Location of Assignment: Remote and Phnom Penh, Cambodia.
Scope of Work:
· Provide technical assistance to NHQC as Cambodia National Government Laboratory and Department of Drug and Food as Cambodia National Regulatory Authority in vaccine lot release:
o Deliver in-country training on good practices for vaccine lot release, including the development of a general policy for independent lot release in line with WHO guidance and requirements/best practices for performing lot release for vaccine, including quality testing across various vaccine platforms
o Provide technical assistance to develop and draft legal and regulatory framework and establish vaccine lot release system (For PQ-ed vaccines, the lot release is based on reliance on or recognition of other NRAs’ Lot Release. For non-PQ-ed vaccines, conducting summary lot protocol review is based
on lot release activity).
Deliverables:
· Training materials for Vaccine Lot Release training, including but not limited to
o Agenda
o Slides/presentation
o Knowledge check
o Training report
· Draft policy and procedure for vaccine lot release
Qualifications:
· At least a master’s degree in fields like biology, chemistry, biochemistry, microbiology, or public health.
· Experience in vaccine research, development, clinical trials, epidemiology, or publichealth is essential.
· At least ten years’ experience working in a public health area with expertise in vaccine, biochemistry, biosimilar and relevant and progressively responsible professional experience in the field of vaccine development programs and its legal policy and framework.
· Strong understanding of country-level contexts with regard to vaccine-preventable diseases and in-depth understanding on international guideline on the use of vaccine, e.g., WHO TRS 978, Annex 2, 2013, and requirements of NRA Lot Release as per WHO GBT.
· Working experience in biotechnology/biopharmaceutical industry strongly preferred
· Work experience in cGLP/cGMP environment
· Demonstrated success in engaging and working with multi-disciplinary teams and proven ability in training and mentoring technical staff.
· Excellent oral and written communication skills in English; knowledge of the local language is desired. Computer proficiency in Word, Excel, PowerPoint, and Internet
The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs works with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
