USP seeks a Quality Management Systems consultant that specializes in Quality Risk
Management and biomanufacturing to support USP by designing and delivering a
customized training program for staff of a biomanufacturing facility on ICH Q9
principles and global best practices. The consultant will develop tailored
training materials, lead interactive sessions, and mentor participants to
strengthen vaccine quality systems and regulatory compliance. This role ensures
knowledge transfer and sustainable capacity building aligned with CEPI
objectives.
**This opportunity is connected to a proposal. Any consultant engagement
is contingent upon contract award.**
Location of Assignment: Remote for design and development and delivery in Senegal
Period of Performance: Est. February 2026 – April 2026
Roles and Responsibilities
The consultant will be responsible for carrying out the following tasks:
- Designing and delivering a customized Quality Risk Management (QRM) training program aligned with ICH Q9 principles
- Developing training materials, in English and French, tailored to biomanufacturing systems
and operations, including interactive case studies and competency assessments.
- Conducting on-site training sessions (3.5–5 days) in French, focusing on:
o QRM tools and techniques for vaccine development and manufacturing.
o Change control, incident response, and risk-based decision-making.
o Preparing for and facilitating risk assessments.
- Mentoring biomanufacturing staff to enable knowledge transfer and sustainability, ensuring they can upskill other team members.
- Providing technical guidance on regulatory expectations, GMP compliance, and quality management systems.
- Coordinating with USP, and other stakeholders to ensure alignment with global best practices and project timelines.
- Preparing high-quality technical reports and deliverables summarizing training outcomes and recommendations for continuous improvement.
Qualifications
- Advanced degree (at least Masters or equivalent) in Biochemistry, Molecular biology, Immunology, Pharmacy, Pharmaceutical Sciences, or related field.
- Minimum 10 years of experience in vaccine development, analytical quality control, and regulatory compliance.
- Demonstrated expertise in implementing QRM (ICH Q9) and GMP principles for biomanufacturing industries
- Demonstrated expertise in:
o Vaccine manufacturing processes and analytical method validation.
o Training design and delivery for technical audiences.
- Excellent written and oral communication skills, including experience in training and mentoring staff.
- Fluency in French and English (required).
Preferred Qualifications
- Familiarity with global regulatory frameworks and dossier preparation for vaccines.
- Experience working in LMIC contexts and with international donors or health authorities.
Application Procedure
Please send your CV, Cover Letter, 3 References, and hourly rate (in USD) to GPH_Procurement@USP.org,
by the closing date of January 30, 2026, When submitting your applications, please write Vaccine Quality Risk Management Training Expert in the email Subject Line of your email.
USP is an independent scientific organization that collaborates with the world's top experts in
health and science to develop quality resources and standards for medicines, dietary supplements, and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. Our programs have reached more than 90 countries across Africa, Asia, and North and South America to strengthen global supply chains and pharmaceutical ecosystems that enable a resilient supply of quality medical products.
USP is delivering a quality risk management training to build foundational knowledge of internationally recognized quality principles and strengthen the capacity of participants to proactively identify and control potential quality issues. The training focuses on improving understanding of best practices, enhancing decision-making and troubleshooting abilities, and supporting the development, manufacturing, and supply of vaccines. The intended impact is improved quality and increased trust in vaccines, ultimately contributing to sustainability and expanded access to life-saving medical products.
