United States of America: Product Quality Assurance Manager
If you are searching for a career/employment opportunity, why not take your time and try out on this one? Here is another Job Opportunity In United States of America: Product Quality Assurance Manager
Organization: Management Sciences for Health
Country: United States of America
Closing date: 10 Dec 2015
Provide quality assurance oversight to the United States Agency for International Development (USAID) – President’s Emergency Plan for AIDS Relief (PEPFAR) funded Supply Chain Management Systems (SCMS) Project and Global Fund’s Pooled Procurement Mechanism (PPM) for the procurement of anti-retroviral, anti-malarial, tuberculosis, and other essential medicines, rapid test kits, food by prescription, male circumcision kits and laboratory consumables for focus low-income countries.
- Manages the global PFSCM QA program.
- Manage the development and review of quality control policies and standard operating procedures.
- Review standard operating procedures (SOPs) to ensure that QA policies and standards are observed for the storage and handling of shipped products.
- Monitor global activities for adherence to QA policies and standards, as well as collection and interpretation of data on QA performance.
- Provide QA consultation to all project functional units, as well as USAID and Global Fund as needed.
- Monitor trends and identify potential quality problems within the supply chain and advise on resolution.
- Oversee transition of SCMS pharmaceutical sampling and testing programs for selected commodities to FHI360.
- Manage sample analyses and track results, on request for PFSCM clients, and recommend product quarantine when necessary.
- Develop communication process for SCMS Procurement Unit to request QA evaluation by FHI360 of potential commodity manufacturers and wholesalers.
- Conduct and/or coordinate on-site quality system assessments and GDP inspections of distribution centers within the PFSCM network.
- Monitor product quality incidents, facilitate investigations, and manage implementation of corrective actions in coordination with the Quality Systems Unit.
- Administer appropriate actions for initiation of product quarantine, recalls and adverse drug event reporting.
- Work with the procurement, freight & logistics, and country leads to ensure that all procurement, forwarding, and in-country storage and handling of both pharmaceutical and non-pharmaceutical commodities maintain quality, safety, and efficacy, as well as compliance with U.S. Government regulations.
- Establish and provide ongoing management of supplier corrective and preventive action implementation, as well as complaint management procedures.
- Oversee importation of quality assurance data to the management information system, including, for approved drugs and equipment, approval by the U.S. Government, documentation, labeling, and regulatory status.
- Additional duties, as assigned, to support PFSCM compliance with the WHO Model Quality Assurance Systems (MQAS) standards and recommendations and QA support for FHI360 QA recommendations for SCMS procurements.
All applications should be submitted by Sunday, November 29, 2015.
- Minimum: Bachelor’s Degree in Microbiology, Chemistry, Biochemistry or related science.
- Proven track record in the quality assurance of pharmaceutical and other commodities for use in the developing world, particularly within the public sector.
- Minimum of 5 years of experience in quality assurance.
- Knowledge of FDA, WHO and in-country regulations with previous Good Manufacturing Practice (GMP) inspection experience.
- Knowledge of the international pharmaceutical and medical supply market, with specific reference to the commodities required for HIV/AIDS prevention, treatment and care.
- Strong interpersonal skills and an ability to work across disciplines and cultures in diverse locations internationally.
- Strong analytical and problem-solving skills and ability to communicate well with major international manufacturing companies, senior level personnel and nontechnical field staff.
- Fluency in English. Fluency in other languages recommended.
- Executive-level computing skills in standard software systems, such as Microsoft Word, Excel, PowerPoint, and Project.
- Willingness to travel internationally, as needed.
- Must be authorized to work in the United States of America.
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