Vacancy: Global Standards 1 (GS1) Consultant

Company Profile

The U.S. Pharmacopeial Convention (USP) USA 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 brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity, or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under a specific written agreement with USP

Job Description

Roles and Responsibilities

• Review the current state of GS1 implementation for medicines in the relevant country.


• Contribute to the development of a national pharmaceutical traceability strategy


• Develop training and workshop materials for GS1 sensitization, adoption and implementation.


• Provides technical support to MRAs on developing GS1 guidelines and related documentation for successful adoption by countries


• Develops scope leading to a national framework, which encompasses:
  
  
  
  • Proposed phases of implementation
  
  
  • Key features of the multi-dimensional e.g. 2D matrix barcode or QR code
  
  
  
  

•  Proposes necessary amendments to the already existing legislation. Legislation must support designing a traceability architecture, supporting policies, and implementing realistic and accomplishable plans.


•  Collaborates with GS1 (global and local office, if any) for their feedback on regulation, guidelines, and training.


• Serves as a technical resource among the PQM+ technical RSS staff with respect to GS1 standards advocacy and implementation for medicines.


• Contribute to the PQM+ Center of Excellence in developing and disseminating PQM+ approach documents related to GS1 standards.


• Provides inputs in the development of PQM+ technical approach tools relevant to GS1.


• Performs other assignments as requested by the program manager West Africa, Senior Technical Advisor, RSS, or the Senior Technical Director.

Required Skills or Experience

Basic Qualifications

• Eight (8) years of experience in the medicines supply chain, pharmaceutical regulation, regulatory functions, and particularly with hands-on experience in the adoption of GS1 codes for medicines.


• Solid knowledge and understanding of the norms and practices of pharmaceutical systems in Africa and Asia.


• Master’s degree or equivalent in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field.

Skills Sought

• Strong written (especially technical writing) and oral communication skills in English (French is a plus)


• Hands-on experience in providing technical assistance to medicines regulatory authorities and manufacturers to adopt the GS1 codes.


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

Preferred Qualifications

• Demonstrated experience working in key functions in the Medicines Supply Chain, an MRA, or an organization providing technical assistance to strengthen medicines quality assurance systems.


• Experience supporting the regulatory authorities in developing the legal provisions on data standards for adoption, type of system, data career, etc.


• Experience designing stepwise processes for GS1 standards adoption and deployment for relevant regulatory functions, including registration/market authorization, lab access and testing, and PMS for product traceability and recall.


• Direct experience implementing USAID-funded programs.

Period of Performance

The anticipated period of performance will begin in January 2024 and run through September 30, 2024.