Job Information
The U.S. Pharmacopeial Convention (USP) Technical Advisor SC-QA in 1, Nepal
Description
Who is USP?
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
Under direct supervision of the Senior Technical Advisor, the TA, SC-QA will provide technical support to the pharmaceutical manufacturing, and medical products supply chain system of Nepal.
How will YOU create impact here at USP?
Under the supervision and direction of the Senior Technical Advisor (STA) –the Technical Advisor:
Developing and implementing quality assurance programs and procedures for the supply chain function of the pharmaceutical organization.
Supporting to maintain organization's quality management system (QMS), conducting risk assessments and quality audits (qualification, and monitoring) throughout manufacturing and supply chain thereby ensuring compliance with regulatory requirements.
Collaborating with internal and external stakeholders to strengthen manufacturing, logistics handling, and procurement processes to ensure quality, safety and efficacy of medicines and medical products throughout lifecycle.
Developing and maintaining key performance indicators (KPIs) for the supply chain function and conducting regular performance monitoring and reporting.
Supporting the implementation of continuous improvement initiatives in the supply chain function, such as lean manufacturing or Six Sigma.
Participating in cross-functional teams or projects related to supply chain quality, as required to ensure availability of quality assured medical products.
Collaborating and supporting team for reporting, documentation, and resource planning to develop periodic reports.
Providing technical oversight of activities to support medicines and medical devices manufacturers in Nepal.
Supporting and leading training delivery to manufacturers, and different points in supply chain management.
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 ith stakeholders, along with the following competencies and experience:
Minimum of 10 + years of relative experience in pharmaceutical sector supply chain system strengthening related work preferably with organizations such as USAID, World Health Organization, or any of the UN agencies.
Bachelor's degree in pharmacy, pharmaceutical science, chemistry, engineering, or science related field of study required.
Experience working in any of the following national regulatory systems, pharmaceutical policy/regulations, pharmaceutical manufacturing, medicine and medical products supply chain, market authorization, post-market surveillance, licensing, or inspections.
Knowledge of international procurement and supply chain management system.
Working understanding of chemistry, manufacturing and controls, good manufacturing, storage, and distribution practices (national legal provisions on drug manufacturing, storage, and distribution system, WHO prequalification, ISO accreditation, and other GMP guidelines)
Strong written (especially technical writing) and oral communication skills
Willingness to travel at least 25% of the time.
Additional Desired Preferences
Direct experience implementing USAID-funded programs.
Minimum of 5+ years of people management experience and skills.
Direct experience with and understanding of WHO guidelines on procurement and supply chain
management system, Global benchmarking tool, etc.
Experience in PIC/S.
Excellent client relationship management skills.
Excellent written and verbal communication skills.
Ability to work in cross-cultural settings.
Ability to demonstrate highest degree of ethics and integrity.
Supervisory Responsibilities
None.
Benefits
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.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to
provide and maintain a workplace free of known hazards, all employees and contingent staff hired
after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved.
Your recruiter will advise accordingly.
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