Quality Manager-Clinical Operations (African based)
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Location:Remote Head Office across Africa
Hours: Full-time
Reports to: Senior Director of Clinical Research - Africa Clinical Research Network
Salary: $50,000 pa (USD) in local currency, dependent on experience
Our Mission:
The Ellison Institute of Technology (EIT) works to develop and deploy advanced technology in pursuit of solving some of humanity’s most challenging and enduring problems. Guided by world leaders, scientists, and entrepreneurs, EIT seeks to accelerate innovation by driving scientific and technological advancements across four humane endeavours: health and medical science, food security and sustainable agriculture, climate change and clean energy, and government innovation and era of artificial intelligence.
Please visit eit.org for more details.
At the Ellison Institute, we believe that an inclusive, collaborative team atmosphere is just as important to our mission as our scientific aims and methods. We strive to build a supportive environment where everyone feels confident taking creative risks toward innovation. We value emotional intelligence and communicating with empathy and respect for others. We foster a team that is curious, has a deep sense of commitment, responsibility, and the resilience needed to achieve excellence.
Job Summary:
We are establishing a clinical research network and are on a mission to revolutionise clinical research in Africa. Our vision is to build a sustainable, African-led research ecosystem that drives health equity and innovation. By establishing a network of world-class clinical research sites and capabilities, we aim to generate the evidence Africa needs to inform health decisions and policies, while cultivating the next generation of African scientific leaders.
Africa has been underrepresented in global clinical research, conducting only 2% of clinical research despite shouldering 25% of the world's disease burden. While there have been significant investments in disease-specific clinical research sites and networks, these approaches have often led to fragmented infrastructure, limited capacity, and reliance on expatriate leadership. Such models have struggled to drive long-term sustainability or meet the broader health needs of African countries and regions beyond narrow therapeutic areas. Consequently, health products and policies in Africa are often informed by data from other settings, which may not fully account for the rich diversity of African populations and local contexts. This lack of locally relevant evidence hinders the development of tailored health solutions that effectively address Africa's unique challenges and priorities.
Our clinical research network is on a mission to transform this landscape. By partnering with leading institutions and trial units across the continent, we will establish a network of clinical research sites that serve two critical goals: diversifying global research and empowering Africa to meet the healthcare needs of its rapidly growing population.
Our network will be designed to catalyze Africa's self-sufficiency in pharmaceutical and vaccine R&D and manufacturing, ensuring the continent can drive its own health innovation agenda. We will establish digital and clinical infrastructure, while prioritizing deep community engagement to foster trust, relevance and impact.
At our sites, we will conduct rigorous, ethical research that puts African populations and priorities at the centre. By generating high-quality local data that reflects the diversity of African contexts, we can accelerate the development and delivery of tailored global health solutions - for Africa, by Africa. Our goal is to build sustainable research capacity that outlasts any single study or funder, empowering African institutions to become global leaders in clinical research and scientific innovation for generations to come.
Overview:
We are seeking a highly skilled Quality Manager with a strong background in clinical research operations to ensure the highest standards of quality in our clinical trials and processes. The successful candidate will ideally be a Clinical Research Associate (CRA), potentially with prior experience in a pharmaceutical company or a Contract Research Organization (CRO). The Quality Manager will work closely with the clinical operations and regulatory teams to monitor and improve clinical trial quality and ensure compliance with industry standards.
Key Responsibilities:
Clinical Trial Quality Oversight:
Implement, manage, and improve the quality management system (QMS) within clinical operations.
Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
Oversee the quality of data collected from clinical trials, ensuring accuracy and consistency.
Conduct quality control audits of clinical trial sites, identifying gaps and recommending corrective actions.
Compliance and Regulatory Management:
Monitor and ensure compliance with applicable local and international regulatory standards, including ICH-GCP and FDA guidelines.
Collaborate with regulatory bodies and ensure proper documentation is maintained for all clinical research activities.
Provide guidance on quality and compliance issues to the clinical research teams and senior management.
Process Improvement and Risk Management:
Identify areas of risk in clinical trial processes and develop mitigation strategies.
Lead initiatives to improve process efficiency and maintain high-quality standards in clinical trial operations.
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for any identified quality issues.
Training and Development:
Develop and deliver training programs related to quality assurance and GCP for clinical staff.
Ensure that all team members are up-to-date on the latest regulatory changes and quality standards.
Mentor junior staff, especially Clinical Research Associates (CRAs), in quality assurance practices.
Collaboration with Key Stakeholders:
Work closely with clinical operations, data management, regulatory affairs and project management teams to ensure seamless coordination across departments.
Collaborate with external partners, such as Donor organisations and CROs, to ensure that outsourced clinical research is conducted in compliance with quality standards.
Audit Preparation and Reporting:
Prepare for and lead internal and external audits, including sponsor audits and regulatory inspections.
Compile and present audit reports, quality metrics, and compliance findings to senior management.
Lead the resolution of any findings from audits, ensuring timely and effective implementation of corrective actions.
Qualifications:
Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (required).
Advanced degree (Master’s or PhD) or equivalent experience in clinical research or pharmaceutical quality management is preferred.
Experience:
Minimum of 5 years of experience in clinical research, with a focus on quality assurance or quality management.
Experience as a Clinical Research Associate (CRA), ideally in a pharmaceutical company or CRO setting.
Familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
Proven experience in auditing clinical trial sites and implementing corrective actions.
Skills and Competencies:
Strong knowledge of clinical trial processes, including regulatory submissions, data management, and trial monitoring.
Excellent analytical and problem-solving skills, with the ability to perform root cause analysis.
Ability to lead and manage multiple projects while maintaining attention to detail.
Strong communication skills with the ability to present complex information clearly.
Ability to work collaboratively in a cross-functional team environment.
Desired Attributes:
Exceptional leadership and mentorship skills, particularly in developing CRAs and quality teams.
A proactive approach to quality improvement, with a focus on innovation and efficiency.
Strong organizational and project management capabilities.
Work Environment:
The Quality Manager will be remote based, with occasional travel to clinical trial sites and partner locations. Flexibility to work in a dynamic environment and handle multiple priorities is essential.
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Hours: Full-time
Reports to: Senior Director of Clinical Research - Africa Clinical Research Network
Salary: $50,000 pa (USD) in local currency, dependent on experience
Our Mission:
The Ellison Institute of Technology (EIT) works to develop and deploy advanced technology in pursuit of solving some of humanity’s most challenging and enduring problems. Guided by world leaders, scientists, and entrepreneurs, EIT seeks to accelerate innovation by driving scientific and technological advancements across four humane endeavours: health and medical science, food security and sustainable agriculture, climate change and clean energy, and government innovation and era of artificial intelligence.
Please visit eit.org for more details.
At the Ellison Institute, we believe that an inclusive, collaborative team atmosphere is just as important to our mission as our scientific aims and methods. We strive to build a supportive environment where everyone feels confident taking creative risks toward innovation. We value emotional intelligence and communicating with empathy and respect for others. We foster a team that is curious, has a deep sense of commitment, responsibility, and the resilience needed to achieve excellence.
Job Summary:
We are establishing a clinical research network and are on a mission to revolutionise clinical research in Africa. Our vision is to build a sustainable, African-led research ecosystem that drives health equity and innovation. By establishing a network of world-class clinical research sites and capabilities, we aim to generate the evidence Africa needs to inform health decisions and policies, while cultivating the next generation of African scientific leaders.
Africa has been underrepresented in global clinical research, conducting only 2% of clinical research despite shouldering 25% of the world's disease burden. While there have been significant investments in disease-specific clinical research sites and networks, these approaches have often led to fragmented infrastructure, limited capacity, and reliance on expatriate leadership. Such models have struggled to drive long-term sustainability or meet the broader health needs of African countries and regions beyond narrow therapeutic areas. Consequently, health products and policies in Africa are often informed by data from other settings, which may not fully account for the rich diversity of African populations and local contexts. This lack of locally relevant evidence hinders the development of tailored health solutions that effectively address Africa's unique challenges and priorities.
Our clinical research network is on a mission to transform this landscape. By partnering with leading institutions and trial units across the continent, we will establish a network of clinical research sites that serve two critical goals: diversifying global research and empowering Africa to meet the healthcare needs of its rapidly growing population.
Our network will be designed to catalyze Africa's self-sufficiency in pharmaceutical and vaccine R&D and manufacturing, ensuring the continent can drive its own health innovation agenda. We will establish digital and clinical infrastructure, while prioritizing deep community engagement to foster trust, relevance and impact.
At our sites, we will conduct rigorous, ethical research that puts African populations and priorities at the centre. By generating high-quality local data that reflects the diversity of African contexts, we can accelerate the development and delivery of tailored global health solutions - for Africa, by Africa. Our goal is to build sustainable research capacity that outlasts any single study or funder, empowering African institutions to become global leaders in clinical research and scientific innovation for generations to come.
Overview:
We are seeking a highly skilled Quality Manager with a strong background in clinical research operations to ensure the highest standards of quality in our clinical trials and processes. The successful candidate will ideally be a Clinical Research Associate (CRA), potentially with prior experience in a pharmaceutical company or a Contract Research Organization (CRO). The Quality Manager will work closely with the clinical operations and regulatory teams to monitor and improve clinical trial quality and ensure compliance with industry standards.
Key Responsibilities:
Clinical Trial Quality Oversight:
Implement, manage, and improve the quality management system (QMS) within clinical operations.
Ensure adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
Oversee the quality of data collected from clinical trials, ensuring accuracy and consistency.
Conduct quality control audits of clinical trial sites, identifying gaps and recommending corrective actions.
Compliance and Regulatory Management:
Monitor and ensure compliance with applicable local and international regulatory standards, including ICH-GCP and FDA guidelines.
Collaborate with regulatory bodies and ensure proper documentation is maintained for all clinical research activities.
Provide guidance on quality and compliance issues to the clinical research teams and senior management.
Process Improvement and Risk Management:
Identify areas of risk in clinical trial processes and develop mitigation strategies.
Lead initiatives to improve process efficiency and maintain high-quality standards in clinical trial operations.
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for any identified quality issues.
Training and Development:
Develop and deliver training programs related to quality assurance and GCP for clinical staff.
Ensure that all team members are up-to-date on the latest regulatory changes and quality standards.
Mentor junior staff, especially Clinical Research Associates (CRAs), in quality assurance practices.
Collaboration with Key Stakeholders:
Work closely with clinical operations, data management, regulatory affairs and project management teams to ensure seamless coordination across departments.
Collaborate with external partners, such as Donor organisations and CROs, to ensure that outsourced clinical research is conducted in compliance with quality standards.
Audit Preparation and Reporting:
Prepare for and lead internal and external audits, including sponsor audits and regulatory inspections.
Compile and present audit reports, quality metrics, and compliance findings to senior management.
Lead the resolution of any findings from audits, ensuring timely and effective implementation of corrective actions.
Qualifications:
Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (required).
Advanced degree (Master’s or PhD) or equivalent experience in clinical research or pharmaceutical quality management is preferred.
Experience:
Minimum of 5 years of experience in clinical research, with a focus on quality assurance or quality management.
Experience as a Clinical Research Associate (CRA), ideally in a pharmaceutical company or CRO setting.
Familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
Proven experience in auditing clinical trial sites and implementing corrective actions.
Skills and Competencies:
Strong knowledge of clinical trial processes, including regulatory submissions, data management, and trial monitoring.
Excellent analytical and problem-solving skills, with the ability to perform root cause analysis.
Ability to lead and manage multiple projects while maintaining attention to detail.
Strong communication skills with the ability to present complex information clearly.
Ability to work collaboratively in a cross-functional team environment.
Desired Attributes:
Exceptional leadership and mentorship skills, particularly in developing CRAs and quality teams.
A proactive approach to quality improvement, with a focus on innovation and efficiency.
Strong organizational and project management capabilities.
Work Environment:
The Quality Manager will be remote based, with occasional travel to clinical trial sites and partner locations. Flexibility to work in a dynamic environment and handle multiple priorities is essential.
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