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.

Responsibilities

  • 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.
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All applications should be submitted by Sunday, November 29, 2015.

Job Requirements

  • 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.

Apply Here

PI922910A41

How to apply:

Apply Here: http://www.Click2Apply.net/d7mgs3pbnn

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