Who is USP?
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Project Overview
The purpose of the USAID-funded Kenya Integrated Pharmaceutical and Supply Chain Technical Assistance project (KIPS) is to ensure sustainable access to and appropriate use of quality-assured and affordable health commodities through a resilient and mature supply chain system and pharmaceutical regulatory services. KIPS will work to strengthen the capacity of local systems, institutions, and individuals to sustainably manage supply chains, for both USAID-procured health commodities and those procured through national/local systems, and to strengthen local pharmaceutical management systems, including quality pharmaceutical services and national regulatory systems.
Brief Job Overview
The Pharmaceutical Management Manager will lead efforts to enhance the national medicines regulatory system in Kenya and provide technical assistance for implementing pharmaceutical management interventions including all regulatory system strengthening related interventions for the DAI led, KIPS project in Kenya. They will work with the Pharmacy and Poisons Board (PPB), DHTP and other stakeholders to identify and implement interventions needed to support PPB to attain and retain the WHO Global Benchmarking maturity level 3 including marketing authorization activities, inspections and risk-based post marketing surveillance. Reporting to the Pharmaceutical Management Director, this position will work in close collaboration with other partners to implement all USP specific technical interventions for the KIPS project and ensure timely and quality delivery of all milestones and deliverables related to RSS and AMR on this project. This position involves a secondment to the DAI/KIPS office, where all project staff will work closely and collaboratively on technical and cross-cutting areas for successful project implementation.
How will YOU create impact in KIPS and here at USP?
Technical Implementation:
- Provide technical leadership to develop and implement interventions necessary to strengthen the regulatory system of Kenya to attain a higher WHO GBT maturity level including but not limited to the areas of marketing authorization, regulatory inspections, licensing of establishments, vigilance, market surveillance and control including risk-based post marketing surveillance, and Antimicrobial stewardship (AMS), etc.
- Work with the Pharmaceutical Management Director and other project staff to optimize processes and resources to improve efficiency in implementing identified RSS interventions.
- Maintain high-quality standards in the implementation of RSS interventions in collaboration with government, private sector counterparts and other project staff.
- Identify and mitigate risks that may affect KIPS’ ability to deliver high quality and timely RSS interventions, and escalate to the Pharmaceutical Management Director.
- Drive the integration of novel thinking in the delivery of RSS interventions, aligning interventions with new thinking and best practices in the sector, making sure to link regulatory system interventions with improving the pharmaceutical supply chain.
- Provide specific technical assistance to the regional offices of PPB and relevant county entities in monitoring the quality of HPTs through post-marketing surveillance, reporting of adverse drug events, and other medicine related issues to ensure patient safety.
- Collaborate with the AMR and Rational Use Manager on designing and implementing interventions aimed at strengthening AMS and appropriate use of medicines and enhancing patient safety.â¯
- Support efforts to enhance regional reliance, work sharing, and other regional collaborative efforts related to RSS.
- Ensure collection of good quality data to support progress monitoring towards achieving relevant RSS and AMS indicators.
- Develop and deliver training programs to enhance RSS and build government counterparts capacity to sustainably move toward technical independence.
- Build and maintain strong relationships with stakeholders involved in RSS and represent the KIPS project at RSS engagements with relevant stakeholders
- Perform any additional regulatory system strengthening activities as may be required by the donor, USP or DAI to support successful project implementation.
Who is USP Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
- Master’s degree or equivalent in Regulatory Science, Pharmacy, Pharmaceutical Science, Public/Global Health, Medicine, Chemistry, Biology, Pharmacovigilance, or related fields
- Minimum of five years of relevant experience in medicine regulation with at least four years of experience working with or supporting a national or regional medicines regulatory authority on one or more of the key regulatory functions including pharmacovigilance and patient safety
- Demonstrated experience with the WHO global benchmarking tool is required.
- Excellent understanding of supply chain and the pharmaceutical development process from pre-clinical development through life cycle management Experience working and currently residing in Kenya is required
- Experience in training, and mentoring government and private sector stakeholders
- Ability to work in a fast-paced environment and quickly adapt to changes and respond to donor demands
- Ability to travel locally
- Excellent written and oral communication skills with ability to produce quality, coherent and informative reports
- Fluency in English is required
Additional Desired Preferences
- Experience in developing and implementing donor funded programs particularly in supporting regulatory system strengthening, patient safety and AMR
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP