Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top authorities 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 hardworking professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. 

Brief Job Overview 

The Promoting of Quality of Medicines Plus (PQM+), a USAID funded global program, was designed to improve access to quality-assured priority medicines and address the proliferation of poor-quality medical products in low- and middle-income countries (LMICs). PQM+ is currently seeking a Technical Advisor for Regulatory Systems Strengthening (RSS) focused cold chain regulation.

How will YOU build impact here at USP?

On this role, you will provide technical assistance to regional regulatory authorities and EFDA to build their capacity to regulate the equipment used in cold chain maintenance of medical products including COVID-19 vaccines in Ethiopia. The candidate must possess a deep understanding of pharmaceutical regulatory environment in low income and middle-income countries. As the Technical Advisor in RSS, you will lead the technical oversight related to the program's objective of strengthening regulatory capacity in registration, inspections, post-marketing surveillance, and other regulatory functions associated with quality assurance of vaccines including the COVID-19 vaccines. 

You will have the following roles and responsibilities:

Provide technical supervision of activities to EPHI, EPI, national and regional regulatory authorities to improve and strengthen the regulatory and quality assurance systems in Ethiopia with focus on QA of COVID-19 vaccines and commodities. 

Create technical reports and papers for publication in reputable journals assigned by technical leads. As well as creating detailed reports of activities conducted.

Participate in outlined activities to improve the quality of the medical products, practice, premises/shops, and services offered.

Engage key national and regional level collaborators in the medical products regulatory and quality assurance system sector paying close attention to the retail aspect.

Collect data and information required for an in-depth understanding of the strength, gaps, weakness, and opportunities in the retail medical products space.

Follow up with the national and regional agencies on agreed action plans, activities, or decisions. As well as implementing agreed tasks.

Support the work and efforts of the Technical Director and the center of excellence to develop technical documents on RSS.

Stay on top of the latest regulatory trends and WHO guidance.

Represent USP in local and regional forums on RSS.

Actively supply to annual programmatic and resource planning process and to the development of quarterly and annual reports.

Collect data for MEL indicators from activities implemented with the national and regional level inspectors, community pharmacy industry and patent and proprietary medicine vendors, and other collaborators on retail regulatory and quality assurance systems. As well as attending meetings requiring their presence.

Job Category: Technical Programs

Requisition Number: TECHN001905

Job Requirements

The successful candidate will have a shown understanding of our mission, commitment to excellence through diverse and equitable behaviors and practices, ability to quickly build credibility with collaborators, along with the following competencies and experience: 

• Minimum of 8 + years of relative experience in RSS 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.

• Subject matter knowledge in any of the following national regulatory systems, pharmaceutical policy/regulations, market authorization, post-market surveillance, licensing, or inspections.

• Knowledge of international regulatory guidelines.

• Confirmed experience in implementing regulatory systems.

• Strong written (especially technical writing) and oral communication skills.

• Willingness to travel at least 25% of the time.

• Additional Desired Preferences

• Direct experience implementing US AID-funded programs.

• Direct experience with the WHO in Global Benchmarking Tools and PIC/S requirements.

• Confirmed experience with regulation of cold chain in the supply chain system.

• Supervisory Responsibilities

• Reports will scale with program growth and will include relevant technical staff.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired: 

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work --from the standards we make to the partnerships and conversations we cultivate.  An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. 

How to Apply

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

Please send CVs to the email address GPHEthiopiaRecruitment@USP.org