Technical Advisor – Supply Chain-Quality Assurance (SC-QA)
Detailed Job description / requirements:
Position: Technical Advisor – Supply Chain-Quality Assurance (SC-QA)
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.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
USP is seeking for a Technical Advisor - Supply Chain-Quality Assurance (SC-QA) in support of PQM+ program implementation in Nepal.
Summary of the Position
Under direct supervision of the Senior Technical Advisor, the TA, SC-QA will provide technical support to the pharmaceutical manufacturing, and medical products supply chain system of Nepal.
Roles and Responsibilities
Under the supervision and direction of the Senior Technical Advisor (STA) –the Technical Advisor:
- Developing and implementing quality assurance program and procedures for manufacturing and supply chain of pharmaceutical products.
- Supporting to maintain organization's quality management system (QMS), conducting risk assessments and quality audits (qualification, and monitoring) throughout manufacturing and supply chain thereby ensuring compliance with regulatory requirements.
- Collaborating with internal and external stakeholders to strengthen manufacturing, logistics handling, and procurement processes to ensure quality, safety and efficacy of medicines and medical products throughout lifecycle.
- Developing and maintaining key performance indicators (KPIs) for the supply chain function and conducting regular performance monitoring and reporting.
- Supporting the implementation of continuous improvement initiatives in the supply chain function, such as lean manufacturing or Six Sigma.
- Participating in cross-functional teams or projects related to supply chain quality, as required to ensure availability of quality assured medical products.
- Collaborating and supporting team for reporting, documentation, and resource planning to develop periodic reports.
- Providing technical oversight of activities to support medicines and medical devices manufacturers in Nepal.
- Supporting and leading training delivery to manufacturers, and different points in supply chain management
- Minimum of 10 + years of relative experience in pharmaceutical sector supply chain system strengthening related work preferably with organizations such as USAID, World Health Organization, or any of the UN agencies.
- Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering, or science related field of study required.
- Experience working in any of the following national regulatory systems, pharmaceutical policy/regulations, pharmaceutical manufacturing, medicine and medical products supply chain, market authorization, post-market surveillance, licensing, or inspections.
- Knowledge of international procurement and supply chain management system.
- Working understanding of chemistry, manufacturing and controls, good manufacturing, storage, and distribution practices (national legal provisions on drug manufacturing, storage, and distribution system, WHO prequalification, ISO accreditation, and other GMP guidelines)
- Strong written (especially technical writing) and oral communication skills
- Willingness to travel at least 25% of the time.
- Direct experience implementing USAID-funded programs.
- Minimum of 5+ years of people management experience and skills
- Direct experience with and understanding of WHO guidelines on procurement and supply chain management system, Global benchmarking tool etc.
- Experience in PIC/S
- Excellent client relationship management skills
- Excellent written and verbal communication skills
- Ability to work in cross-cultural settings.
- Ability to demonstrate highest degree of ethics and integrity.
Interested candidates should submit cover letter, CV by email to GPHNepalRecruitment@USP.org clearly stating Technical Advisor - Supply Chain-Quality Assurance (SC-QA) in the subject line of the e-mail. Or online application can be submitted through the USP website https://recruiting.ultipro.com/UNI1066/JobBoard/7edcf3b7-2288-c99a-0ece-44b0a1e5cfe9/OpportunityDetail?opportunityId=07fa9a9d-85dd-469e-940f-5b3cbd6c0f57
Application Deadline: September 20, 2023