Management Sciences for Health

  • Product Quality Assurance Manager

    Grade
    K
    Job ID
    13-10011
    Location
    US-VA-Arlington
    # of Positions
    1
    Group/Office
    PHT
    Dept/Unit
    GEN (General)
    Project/Program
    A000 - None Specified
    Reports To
    Senior Quality Unit Manager, Quality Management Unit
  • Overview

    The Product Quality Assurance (QA) Manager is expected to provide quality assurance oversight to PFSCM projects 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. The Product QA Manager is responsible to provide guidance and insights into the quality assurance activities of the unit especially with regards to chemistry, pharmaceutical, and regulatory matters. The Manager also assists in developing product quality compliance and risk mitigation strategies and is expected to work across units and reach out to other technical and scientific specialists.

    The Product QA Manager is the key contact to ensure ongoing quality assurance related processes under PFSCM are appropriately synchronized with the Global Supply Chain Unit and other units as necessary.

    The Product QA Manager is responsible to conduct regulatory quality audits based on current GMP/GDP guidelines and represent PFSCM’s QA policies and standards with clients and industry-related occasions.

    Must be authorized to work in the United States or the Netherlands and this role has an application deadline of 5/2/18

    Specific Responsibilities

    Client Interaction (50%)

    • Manage PFSCM’s global quality assurance program.
    • Provide QA consultation to all project functional units as well as clients as needed.
    • Maintain and build client relationships on quality assurance matters.
    • Ensure 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 client regulations, working with the Global Supply Chain Unit.
    • Provide technical assistance as requested on product regulation and compliance issues including product registration, inspection, testing, product control and compliance.
    • Prepare internal reports and/or publish findings, as appropriate.
    • Provide ongoing management of supplier corrective and preventive action implementation, as well as complaint management procedures.

     

    Product Master/Supplier Pre-Qualification (25%)

    • Maintain product master file data in the ERP system.
    • Manage review of quality control policies and standard operating procedures, including continuous improvement activities, to ensure that policies and standards are observed for the storage and handling of shipped products.
    • Keep abreast of product quality regulatory related industry trends and information for knowledge sharing and trend monitoring.
    • Review and critique chemical analysis and physical examination reports for compliance to standards and assign product rejection or acceptance.
    • Monitor global activities for adherence to QA policies and standards, as well as collection and interpretation of data on QA performance.
    • Monitor internal trends, proactively identify potential quality problems within the supply chain, and advise on resolution.
    • Oversee pharmaceutical sampling and testing programs for selected commodities.
    • Develop the strategy and conduct on-site quality system assessments and GMP inspections of potential commodity manufacturers and wholesalers and liaise with PFSCM’s Procurement Unit on QA strategies for selection.
    • Provide quality assurance data to the management information system, including, for approved drugs and equipment, documentation, labeling, and regulatory status.

     

    Incident Management (25%)

    • Administer appropriate actions for initiation of product recalls and adverse drug event reporting.
    • Monitor quality control incidents, facilitate investigations, and manage implementation of corrective actions.
    • Manage sample analyses, track results, and recommend product quarantine when necessary.

    Qualifications and Experience

    Education:

    Required:

    • Post-graduate education in Pharmacy required.

    Preferred:

    • Degree in a laboratory science or public health desirable. 

     

    Experience:

    Required:

    • 8+ years’ experience with proven track record in the quality assurance of pharmaceutical and other commodities for use in the developing world, particularly within the public sector.
    • 5+ years’ experience in pharmaceutical analysis, and product quality assessments and standards.
    • 3+ years’ experience in product regulation. 

     

    Knowledge and Skills:

    • Knowledge of pharmaceutical and regulatory requirements for international markets such as United States, European Union, India, and Africa.
    • Experience with pharmaceutical product dossier compilation and review.
    • Experience in pharmaceutical laboratory commodities, tests, equipment, and techniques.
    • Experience working with developing countries is a plus.
    • Knowledge of FDA, WHO, in-country regulations, and stringent regulatory authorities with previous Good Manufacturing Practice (GMP) inspection experience.
    • Knowledge of statistical regimes to be applied in the sampling and testing of manufactured products as recommended by ASQC, the FDA, or international GMP regulations.
    • 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 in diverse locations internationally.
    • Strong analytical and problem-solving skills at a senior level with major international manufacturing companies.
    • Excellent written and oral communication skills. English fluency required, additional international business language fluency is preferable.
    • Advanced computing skills in standard software systems, such as Microsoft Office suite.
    • Willingness and availability to travel up to 40%, and perform other duties as needed.

     

    Core Job Competencies:

    Navigating the Environment:

    • Perspective, dealing with ambiguity, organizational agility, political savvy, and strategic agility.

    Ensuring Delivery of Results:

    • Functional/technical skills, client focus, managing through systems, managing and measuring work, negotiating, information sharing, process management, priority setting, problem solving, and timely decision making.

    Leading with Credibility:

    • Managing others, building effective teams, conflict management, managing vision and purpose, integrity and trust, motivating others, approachability, and developing direct reports and others.

    Core Personal Competencies:

    • Ethics and values, integrity and trust; with strong listening, presentation, writing and communication skills.
    • Demonstrated computer skills; knowledge of appropriate methods for data analysis and reporting.

    Background Information

    Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in over 150 countries with policy makers, health professionals, and health care consumers to improve the quality, availability and affordability of health services. Working with governments, donors, non governmental organizations, the private sector, and health agencies, MSH responds to priority health problems such as HIV & AIDS; tuberculosis; malaria; maternal, newborn and child health; family planning and reproductive health; and chronic non-communicable diseases such as cancer, diabetes, and lung and heart disease. Through strengthening capacity, investing in health systems innovation, building the evidence base, and advocating for sound public health policy, MSH is committed to making a lasting difference in global health.

    EEO Statement

    Management Sciences for Health is an equal opportunity employer offering employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, citizenship, physical or mental disability, or veteran status.

    Reports To

    Senior Quality Unit Manager, Quality Management Unit
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