Job ID 89841
The U.S. Pharmacopeial Convention (USP) USP 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’s fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
The Senior Technical Advisor Regulatory Systems Strengthening (STA-RSS) will support PQM+ Nepal program to strengthen the capacity of Department of Drug Administration, National Medicine Laboratory, Public and Private Manufacturers and other relevant stakeholders to improve the efficiency & sustainability of health product regulatory i.e., quality assurance and quality control processes at various levels of product life cycle in public and private sectors of Nepal.
How will YOU create impact here at USP?
Under the direct supervision of Deputy Chief of Party (DCoP), STA-RSS will lead and support the PQM+ Nepal program RSS team in overall implementation of workplan activities at national, sub national and local governing unit levels. The STA -RSS will lead and support the technical team in day-to-day activities on regulatory systems strengthening those include (but not limited to) Registration/Market Authorization, Licensing Establishment, Regulatory Inspection, and Market Surveillance & Control, Laboratory Testing and Clinical Trails oversight etc. STA-RSS will also coordinate with technical counterparts and support the program to support private sector health product Manufacturers, Testing Laboratories and Clinical Research organization to build their capacity and acquire national and international certifications and accreditations. The specific activities include,
A- Regulatory Systems Strengthening
- Provide technical assistance to Department of Drug Administration (DDA) and National Medicine Laboratory (NML) to strengthen their regulatory inspection component to improve the quality and efficiency of inspection and to ensure the compliance with Good Manufacturing Practices, Good Laboratory practices and quality control laboratories, importers.
- Support DDA and stakeholders to establish transparent and efficient licensing and product market authorization mechanisms for industries and importers to improve the patient access to quality, effective, safe and economical health products through local manufacturing, imports and distribution.
- Help DDA and NML to strengthen market surveillance & control function of regulatory system to identify and removal of substandard and falsified health products from the market and safeguard the public health.
- Build the capacity of national medicine laboratory (NML) to establish a capable, efficient and accredited network of health product testing laboratories at national and sub national level. Support NML to optimize its testing capacity (types and number of tests) and quality of product testing through implementation of evidence-based approaches.
- Support DDA, NML and other stakeholders from health and educational and industry sectors to strengthen their capacities and capabilities on regulatory oversight and implementation of clinical studies in the country.
B- Public & Private Sector Manufacturing
- Coordinate and collaborate with different stakeholders to support private manufacturers (medicines & health technologies) to optimize their capabilities to acquire WHO Prequalification and other international certifications for targeted essential health products and contribute into in-country, regional and global demand and supply of quality assured products.
- Facilitate Public sector manufacturers to optimize its quality assurance and production capabilities to manufacture health products complying with national regulatory standards.
- Health Technology Manufacturer: Support technical team in identifying priority HTP and manufacturer and strengthen for a quality product through technical support and capacity strengthening.
- Communication & Coordination: Regular communication and coordination with internal team members and DDA, NML and other stakeholders whenever required.
- Leadership & Management: day-to-day management of planned activities, support team in weekly and quarterly planning of activities, take a lead role in regulatory system and services for the designated technical team, supportive supervision to the team on a regular basis.
- Monitoring & Evaluation: monitor planned activities on regular basis with semi-annual evaluation.
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:
- Master’s degree in pharmacy, chemistry, microbiology, or related field; a higher degree will be an advantage.
- At least 15 years of experience after graduation having engaged in pharmaceutical sector related Good Practices such as Good Manufacturing Practices (GDP), Good Distribution Practices (GDP), Good Storage Practices (GSP), and good laboratory practices (GLP) norms in related fields.
- Experienced on WHO prequalification process for MNCH and FP products is desirable.
- Detailed experience and knowledge about regulatory system strengthening (RSS system and function) and manufacturing of HTP.
- In depth knowledge about WHO, ICH and PIC/S guidelines on quality risk management and risk-based approaches
Additional Desired Preferences
- Experience in managing virtual teams based in low- and middle-income countries.
- Expertise in health systems strengthening.
- Pharmacist, Physician, or other health profession qualification highly desirable.
- Proof of experience leading effective, timely, and quality implementation of donor-funded (particularly USAID-funded) global health or international development projects.
- Good understanding of and experience working with USAID compliance rules and regulations.
- Significant experience working with high level officials in USAID and country governments.
- Strong people management skills, including of virtual, matrixed teams.
- Excellent client relationship management skills.
- Excellent written and verbal communication skills.
- Ability to work in cross-cultural settings.
- Ability to demonstrate the highest degree of ethics and integrity.
- Technical Advisor CMC
- Technical Advisor QA/QC
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.
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.
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.
Job Category Technical Programs
Job Type Full-Time
Application process: External Link