Description
Brief Job Overview
The Senior Technical Advisor reports to the PQM+ CMC Senior Technical Advisor.
The incumbent focuses on leading the delivery of technical assistance to medical product manufacturers and NMRAs within Africa.
The primary goal is to enhance capacities and capabilities to produce quality-assured essential medical products.
This involves providing technical guidance, oversight, and support to both manufacturers and regulatory bodies.
Externally, the Senior Technical Advisor collaborates with a wide array of stakeholders, including medical product manufacturers, the World Health Organization (WHO), National Medicines Regulatory Authorities (NMRAs), the United States Agency for International Development (USAID) and other partners.
These collaborations are vital for achieving the shared objective of increasing the availability of high-quality medical products in the region.
Additionally, the Senior Technical Advisor will provide thought leadership within and outside of the organization. Internally, the technical advisor works collaboratively with PQM+ teams and other departments within the United States Pharmacopeia (USP). Internal coordination ensures a comprehensive and effective approach to technical assistance and quality improvement.
How will YOU create impact here at USP?
Senior Technical Advisor, PQMPlus – Chemistry, Manufacturing and Controls:
Global/Regional leadership: Lead in planning and delivery of PQM+ technical assistance.
Industry support: Assist manufacturers and regulators to increase the supply of quality-assured essential medical products.
Quality Auditing: Conduct manufacturer audits to identify GMP (Good Manufacturing Practices) and QMS (Quality Management System) gaps to ensure compliance with international standards.
Training and Guidance: Train and provide technical guidance to manufacturers in identified areas to facilitate skill development and process improvement.
Technology Transfer: Lead technology transfer between sending and receiving units.
Product Development: Guide manufacturers in product development offering expertise in CMC to enhance the quality and performance of medical products.
Risk Mitigation: Support the development of mitigation and contingency plans, ensuring preparedness for potential challenges in manufacturing and quality assurance.
International Standards: Advocate for and ensure the adoption of international quality standards, aligning manufacturing practices with global best practices. Regulatory Assistance: Assist manufacturers in GMP, GLP (Good Laboratory Practices), technology transfer, dossier development, regulatory submissions, and other areas.
Program Growth: Actively participate in the annual programmatic and resource planning process contributing to the growth and expansion of impact in the region.
Collaboration: Work closely with other program technical teams to ensure the deployment of holistic implementation strategies fostering cross-functional collaboration.
Support Network: Provide support and expertise to other technical teams at the program's headquarters and within countries promoting knowledge sharing and synergies.
Document Review: Conduct product peer-reviews of documents ensuring accuracy, compliance, and quality in technical materials.
Continuous Learning: Stay updated on the latest industry technologies and regulatory requirements incorporating new knowledge into program activities.
Thought Leadership: Demonstrate thought leadership by developing and contributing to white papers, journal articles, and participating in conferences, working groups, and forums at the global and regional levels.
Technical Advisor, PQMPlus – Chemistry, Manufacturing and Controls:
Regional leadership: Lead in planning and delivery of PQM+ technical assistance.
Industry support: Assist manufacturers and regulators to increase the supply of quality-assured essential medical products.
Quality Auditing: Conduct manufacturer audits to identify GMP (Good Manufacturing Practices) and QMS (Quality Management System) gaps to ensure compliance with international standards.
Training and Guidance: Train and provide technical guidance to manufacturers in identified areas to facilitate skill development and process improvement.
Technology Transfer: Guide technology transfer between sending and receiving units
Product Development: Guide manufacturers in product development offering expertise in CMC to enhance the quality and performance of medical products.
Risk Mitigation: Support the development of mitigation and contingency plans, ensuring preparedness for potential challenges in manufacturing and quality assurance.
International Standards: Advocate for and ensure the adoption of international quality standards, aligning manufacturing practices with global best practices.
Regulatory Assistance: Assist manufacturers in GMP, GLP (Good Laboratory Practices), technology transfer, dossier development, regulatory submissions, and other areas.
Program Growth: Actively participate in the annual programmatic and resource planning process contributing to the growth and expansion of impact in the region.
Collaboration: Work closely with other program technical teams to ensure the deployment of holistic implementation strategies fostering cross-functional collaboration.
Support Network: Provide support and expertise to other technical teams at the program's headquarters and within countries promoting knowledge sharing and synergies.
Document Review: Conduct product peer-reviews of documents ensuring accuracy, compliance, and quality in technical materials.
Continuous Learning: Stay updated on the latest industry technologies and regulatory requirements incorporating new knowledge into program activities.
Thought Leadership: Demonstrate thought leadership by contributing to white papers, journal articles, and participating in conferences, working groups, and forums at the global and regional levels.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
Senior Technical Advisor, PQMPlus – Chemistry, Manufacturing and Controls
:
BS, MS or Ph.D. degree in pharmacy, pharmaceutical science, chemistry, chemical engineering, or related field of study.
Minimum of 15 years of experience in medical products manufacturing.
Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings.
The candidate should have demonstrated leadership and managerial skills, including experience in leading cross-functional teams, and managing projects in a pharmaceutical manufacturing environment.
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.
Strong written (especially technical writing) and oral communication skills.
Willingness to travel up to 25% of the time.
Technical Advisor, PQMPlus – Chemistry, Manufacturing and Controls
:
BS, MS or Ph.D. degree in pharmacy, pharmaceutical science, chemistry, chemical engineering, or related field of study.
Minimum of 10 years of experience in medical products manufacturing.
Subject matter expert in manufacturing processes, comparability/feasibility studies, stability studies, analytical development, and regulatory filings.
The candidate should have demonstrated leadership and managerial skills, including experience in leading cross-functional teams, and managing projects in a pharmaceutical manufacturing environment.
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.
Strong written (especially technical writing) and oral communication skills.
Willingness to travel up to 25% of the time.
Additional Desired Preferences
USAID Program Experience: Direct experience in implementing programs funded by the United States Agency for International Development (USAID), demonstrating a strong understanding of USAID's policies and procedures.
Extensive GMP Experience: More than 10 years of hands-on experience working in a Good Manufacturing Practices (GMP) compliant medical product manufacturing facilities with a deep understanding of manufacturing processes, quality control, and regulatory compliance.
Health Sector Expertise: Substantial experience in one or more of the following health areas: HIV/AIDS, malaria, tuberculosis (TB), neglected tropical diseases (NTDs), antimicrobial resistance (AMR), and maternal, newborn, and child health (MNCH). This expertise is valuable for addressing specific health challenges.
Technical Specialization: Proficiency in technical areas such as water systems validation, sterility assurance, HVAC (Heating, Ventilation, and Air Conditioning), cleaning procedures, test method development, process validation formulation and other relevant areas within pharmaceutical manufacturing.
Regulatory Affairs: Direct experience with a deep understanding of WHO (World Health Organization) pre-qualification processes and/or other regulatory authority registration procedures for medical products.
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