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Specialist, QA Regulatory Harmonization, Regional Production & Capacity Building(m/w/x)
Overseeing product registration, distribution, and local production strengthening for global health initiatives. Advanced degree in health science and regulatory affairs certification required. Work with diverse global partners for health initiatives.
Requirements
- Advanced degree in health science or equivalent
- Certification in regulatory affairs
- QA management experience in public/private sector
- Experience with QA regulatory policies and frameworks
- Experience with external partner engagement
- Knowledge in developing QA policies and tools
- Experience in matrix organizations and cross-functional teams
- Minimum 6 years experience in QA/regulatory affairs
- Work experience in Global Fund supported countries
- Excellent English and good French knowledge
- Ability to lead and collaborate in teams
Tasks
- Support regulatory systems and quality assurance implementation
- Manage registration, storage, and distribution requirements
- Oversee market surveillance and quality control testing
- Select service providers for regulatory and QA matters
- Build regional manufacturing capacity and regulatory strengthening
- Develop the Global Fund Regulatory Systems blueprint
- Review funding requests to enhance country QA capacities
- Coordinate supply operations for aligned regulatory approaches
- Partner with authorities on regional harmonization and reliance
- Integrate QA management systems with enterprise resource tools
- Enhance QA policies, guidelines, and governance models
- Advise stakeholders on country QA maturity assessments
- Identify system weaknesses and capacity gaps
- Create technical briefs for funding request applicants
Education
- Master's degree
Languages
- English – Business Fluent
- French – Business Fluent
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Specialist, QA Regulatory Harmonization, Regional Production & Capacity Building(m/w/x)
Overseeing product registration, distribution, and local production strengthening for global health initiatives. Advanced degree in health science and regulatory affairs certification required. Work with diverse global partners for health initiatives.
Requirements
- Advanced degree in health science or equivalent
- Certification in regulatory affairs
- QA management experience in public/private sector
- Experience with QA regulatory policies and frameworks
- Experience with external partner engagement
- Knowledge in developing QA policies and tools
- Experience in matrix organizations and cross-functional teams
- Minimum 6 years experience in QA/regulatory affairs
- Work experience in Global Fund supported countries
- Excellent English and good French knowledge
- Ability to lead and collaborate in teams
Tasks
- Support regulatory systems and quality assurance implementation
- Manage registration, storage, and distribution requirements
- Oversee market surveillance and quality control testing
- Select service providers for regulatory and QA matters
- Build regional manufacturing capacity and regulatory strengthening
- Develop the Global Fund Regulatory Systems blueprint
- Review funding requests to enhance country QA capacities
- Coordinate supply operations for aligned regulatory approaches
- Partner with authorities on regional harmonization and reliance
- Integrate QA management systems with enterprise resource tools
- Enhance QA policies, guidelines, and governance models
- Advise stakeholders on country QA maturity assessments
- Identify system weaknesses and capacity gaps
- Create technical briefs for funding request applicants
Education
- Master's degree
Languages
- English – Business Fluent
- French – Business Fluent
About the Company
The Global Fund to Fight AIDS, Tuberculosis and Malaria
Industry
Healthcare
Description
The Global Fund aims to end AIDS, tuberculosis, and malaria as epidemics through innovative health solutions.
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