Daniel Karimi Email and Phone Number
Have you ever wondered how much effort goes into making medicines safe and effective? Try picturing the interconnection of complex processes and stringent standards to the colossal scale of manufacturing and delivery of health products. That’s where I come in. As a Senior Technical Advisor in the pharma-biotech sector focusing on quality assurance and regulatory systems, I help guarantee that the medicines I/ you/ we use daily are safe, effective and reliably available where needed.My career of 15+ years has been a trek across the healthcare terrain in Africa and Asia. I have applied myself to projects that have made a difference from enabling quality compliance to reinforcing regulatory capabilities for supply chain oversight. I have assisted pharmaceutical manufacturers in several countries to achieve high compliance standards. I create practices and procedures that demystify complicated regulatory measures. Currently at USP, in USAID’s Promoting the Quality of Medicines Plus (PQM+) Program, I manage projects that enhance compliance with the regulations and quality assurance of the medicines to meet global standards.I have led the creation of more than 25 technical tools such as frameworks, action plans, guidelines, and SOPs that facilitate quality compliance and oversight between product manufacture and use. I have performed over 10 GMP assessments, assisted manufacturers in solving compliance issues, and participated in the WHO prequalification of essential medicines. Further, I have facilitated the capacity-building of over 150 regulatory, procurement, and hospital staff across multiple countries on GMP, GDP, and GSP, enhancing quality assurance systems and regulatory compliance.As a Quality Assurance Manager in manufacturing, I led my team to an over 15% decrease in product defect rate by enforcing strict internal controls and staff training. Being proactive in my approach, production efficiency increased by about 20%.I oversaw quality assurance of medicines and equipment from procurement to use in a multi-year multi-million dollar USAID-funded project implemented by Chemonics International Inc.I am passionate about consistently improving healthcare quality, stakeholder collaboration, and optimizing supportive frameworks for human health.
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Senior Technical Advisor, Chemistry, Manufacturing And Controls, Regulatory Systems StrengtheningUs PharmacopeiaKenya -
Senior Technical Advisor, Chemistry, Manufacturing & Controls, Regulatory Systems StrengtheningUs Pharmacopeia Mar 2021 - PresentThe Promoting the Quality of Medicines Plus (PQM+) program is a USAID-funded initiative that assists low—and middle-income countries in strengthening their medical product quality assurance systems.𝐃𝐮𝐭𝐢𝐞𝐬• Develop and implement technical frameworks, guidelines, policies, and procedures to streamline compliance and regulation in pharmaceutical supply chains.• Undertake manufacturer GMP inspections and assist in addressing compliance gaps.• Offer technical support and guidance to manufacturers on WHO prequalification for medicines. • Assist manufacturers in developing and implementing strategies for quality improvement, market access, growth, and sustainability. 𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐦𝐞𝐧𝐭𝐬• Created more than 25 tools that enhanced the compliance and regulation of health products across the supply chain in different regions.• Enhanced GMP compliance standards among manufacturers by undertaking more than ten assessments in different countries.• Effectively supported the WHO pre-qualification process of 5 medicines for manufacturers in different countries.• Conducted training for over 150 healthcare professionals, contributing to more effective quality management practices in manufacturing, distribution, health facilities, and regulation.• Created one procedure for harmonized regulation of active pharmaceutical ingredients in Africa
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General Manager/Quality Assurance ManagerNjimia Kenya Ltd Oct 2015 - Dec 2020Kenya𝐃𝐮𝐭𝐢𝐞𝐬• Maintained corporate compliance with all the regulatory requirements.• Established internal quality control mechanisms to deal with high incidences of product defects and failure to meet GMP requirements.• Coordinated and conducted staff capacity building on quality assurance and regulatory compliance• Engaged with stakeholders to better company and sector opportunities.• Assisted in corporate-level strategic management including developing effective quality programs and overall operations.𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐦𝐞𝐧𝐭𝐬• Successfully set up a functional quality management system at the facility. • Led the manufacturing productivity growth by 50% over three years while maintaining quality.• Better quality and employee satisfaction via training initiatives, where internal quality indicators were elevated by 25 percent.• Led in developing the company’s first corporate strategic plan that fostered growth and quality. -
Quality Assurance ManagerChemonics International Sep 2012 - Sep 2015Chemonics Pharma LLC, through the USAID Kenya Pharma Project, created a secure and reliable supply chain that ensured a sustainable availability of quality-assured medicines for healthcare needs in Kenya.𝐃𝐮𝐭𝐢𝐞𝐬• Managed local and international outsourced laboratories to ensure adequate testing of health products.• Engaged KEMSA and NASCOP to manage stock-out risks while ensuring supply chain quality assurance.• Liaised with local regulatory authorities to ensure supply chain compliance with national standards.• Monitored and evaluated project performance metrics using data-driven insights to improve operational efficiency and quality compliance.𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐦𝐞𝐧𝐭𝐬• Supervised product quality assurance in the $500 million pharmaceutical supply chain project.• Inspected 12 of the contracted manufacturers for compliance with WHO GMP guidelines.• Led technical support and deployment of software in two Kenyan drug analysis laboratories, resulting in improved testing capacity and accuracy.• Provided critical quality management input that ensured adherence to USAID and Chemonics International’s quality systems, and ISO 9001 principles, bolstering project procedural consistency and operational efficiency.• Instituted a quality surveillance system across the supply chain that contributed to high-impact healthcare delivery. -
Quality Assurance Operations ManagerOsschemie (K) Limited Aug 2010 - Aug 2012Osschemie (K) Limited is a pharmaceutical company in Kenya that manufactures generic medicines and disinfectants.𝐃𝐮𝐭𝐢𝐞𝐬• Ensured company operations met GMP and regulatory standards.• Developed and maintained quality, safety, health, and environmental compliance programs, aligning operations with industry and regulatory requirements.• Conducted internal audits to identify process improvement opportunities.• Led staff training programs.• Managed budgeting and cost control measures across production, storage, and distribution, aiming to optimize resource utilization and reduce operational costs.𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐦𝐞𝐧𝐭𝐬• Enhanced operational compliance with GMP and regulatory standards.• Increased production efficiency by about 15% through process improvements through continuous improvement initiatives.• Reduced operational costs by 10% by implementing effective budgeting practices and cost controls in resource utilization.• Streamlined storage and distribution processes, decreasing product handling times and improving overall supply chain efficiency.
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Chief PharmacistThe Nairobi Women'S Hospital Group Mar 2008 - Jul 2010The Nairobi Women's Hospital Group is a leading healthcare provider in Kenya, specializing in women's and children's health. 𝐃𝐮𝐭𝐢𝐞𝐬• Oversaw pharmaceutical operations across the hospital group, managing end-to-end medication supply chain processes, including procurement, inventory, and distribution.• Managed the financial performance of the pharmacy department, including billing processes, profit and loss (P&L) responsibilities, and financial reporting.• Led initiatives to promote rational drug use by conducting regular prescription audits, ensuring safe and appropriate medication practices.• Collaborated with hospital management and clinical teams to optimize medication utilization, enhance patient outcomes, and support healthcare cost-effectiveness.• Developed and implemented policies for efficient pharmacy operations, aligning department objectives with overall hospital goals.𝐀𝐜𝐡𝐢𝐞𝐯𝐞𝐦𝐞𝐧𝐭𝐬• Increased pharmacy department profitability by 15% through effective P&L management and cost-control measures across supply chain operations.• Improved medication safety and reduced inappropriate prescribing by 25% through rigorous prescription audits and rational drug use programs.• Reduced medication stockouts by 20% by implementing efficient inventory management practices and supplier coordination strategies.• Enhanced billing accuracy and reduced billing errors by 30%, streamlining the revenue cycle for the pharmacy department.• Strengthened financial accountability in pharmacy operations, achieving a 10% reduction in operational costs through optimized resource allocation and waste reduction. -
District PharmacistGovernment Of Kenya Dec 2004 - Feb 2008Worked with Government of Kenya at Hospital in Moyale, Makueni, Nairobi Districts.𝐃𝐮𝐭𝐢𝐞𝐬• Coordinating pharmaceutical services across the district hospital, health centres, and dispensaries to ensure smooth operations and effective service delivery.• Overseeing the proper storage and handling of pharmaceuticals, ensuring compliance with safety and regulatory standards.• Managing the distribution and usage of medications, ensuring that they are delivered in a timely and efficient manner to all healthcare facilities.• Maintaining accurate records and documentation of drug stocks, usage, and distribution to ensure accountability and transparency.• Ensuring adherence to the Essential Drugs List (EDL) in procurement processes and monitoring for compliance with national and international pharmaceutical guidelines.
Daniel Karimi Education Details
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Brunel University LondonMaster Of Science In Public Health -
Certificate In Leading Strategic Innovation In Healthcare -
World Bank InstituteCertificate In Basics Of Health Economics
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Master Of Business Administration - Mba -
Pharmaceutical Sciences
Frequently Asked Questions about Daniel Karimi
What company does Daniel Karimi work for?
Daniel Karimi works for Us Pharmacopeia
What is Daniel Karimi's role at the current company?
Daniel Karimi's current role is Senior Technical Advisor, Chemistry, Manufacturing and Controls, Regulatory Systems Strengthening.
What schools did Daniel Karimi attend?
Daniel Karimi attended Brunel University London, University Of Warwick - Warwick Business School, World Bank Institute, Africa Nazarene University, University Of Nairobi.
Who are Daniel Karimi's colleagues?
Daniel Karimi's colleagues are Juliet Konje, Susan Clagett, Ashraf Khan, Manish Alina, Hana Sinkie Keno, Lisa Corbin, Ivonne Zuniga W..
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