Job Information
The U.S. Pharmacopeial Convention (USP) Technical Manager, Good Manufacturing Practices in Kebele 01/02, Ethiopia
Description
Summary of the Position
This is a non-supervisory position and is an individual contributor role
It is available in USP offices in Ethiopia, Kenya, Ghana, or Nigeria
This a strategic level position in order to expand competencies and capabilities in medical products manufacturing
The incumbent will be responsible for providing technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products
The incumbent will interface with internal USP departments as well as manufacturers of medical products and regulators
Roles and Responsibilities
Lead in the provision of technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.
Provide technical assistance to manufacturers in GMP, technology transfer, and dossier development and submission through audits, trainings, and deployment of tools and approaches to ensure adoption of international quality standards.
Conduct audits to assess compliance with international standards from WHO Prequalification process and support manufacturers to develop strategies and tools to address deviations and non-compliance identified
Identify CMC risks and support the development of mitigations and contingency plans.
Collaborate with PQM+ to provide technical assistance and oversight to manufacturers and regulators to achieve the objectives of increasing the supply of quality-assured essential medical products.
Provides oversight for local CMC staff, local partners and consultants involved in delivery of manufacturing support
Actively contribute to the engagement of the private sector stakeholders to facilitate public-private collaboration to support local manufacturing of quality pharmaceuticals and medical products
Work closely with teams to support development and deployment of strategies
Review and provide timely inputs into key project deliverables including technical and donor reports
Keep abreast of the latest manufacturing trends and regulation requirements
Represents USP in international forums on manufacturing
Basic Qualifications
Minimum of 10 years of experience in pharmaceutical manufacturing
Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings
Thorough understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices for medicines, packaging, and other relevant areas
Knowledge of regulatory requirements related to the development and manufacture of medicines in all phases of clinical development
Direct experience with regulatory authority registration processes
BS, MS, or Ph.D. degree in, pharmaceutical science, chemistry, engineering, or science related field of study required
Strong written (especially technical writing) and oral communication skills
Willingness to travel up to 25% of the time
Preferred Qualifications
Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products
Direct experience with and understanding of WHO pre-qualification and/or other regulatory authority registration processes
Job Category Technical Programs
Job Type Full-Time