TITLE: Product Quality Assurance Manager
REPORTS TO: Senior Quality Unit Manager
LOCATION: Project Management Office in Arlington, Virginia, U.S. (PMO- US), or Woerden, Netherlands (PMO-NL)
The Partnership for Supply Chain Management (PFSCM) brings together multiple private sector and non-governmental organizations that are among the most trusted names in supply chain management and international public health and development in the world. PFSCM has been recognized internationally for its work to save lives through stronger public health supply chains; the partnership won two supply chain distinction awards from the European Supply Chain and Logistics Summit in 2010 and was a finalist in the 2012 Supply Chain Innovation Award Competition sponsored by the Council of Supply Chain Management Professionals (CSCMP) and SupplyChainBrain.
The Global Fund to Fight AIDS, Tuberculosis and Malaria is a major financing institution in the fight against these diseases in 140 countries. The Global Fund selected PFSCM to be its primary Procurement Agent for Global Fund principal recipients, under its Pooled Procurement Mechanism aimed at ensuring a cost-effective and efficient procurement process that meets all the Global Fund standards for a Procurement Agent. This service provides support to countries to resolve procurement bottlenecks and supply chain management challenges and to facilitate timely access to pharmaceuticals and other health products.
In addition, PFSCM implements other supply chain management projects with other client/donors including the Malaria Consortium and several developing country governments.
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.
- Manage PFSCM’s global quality assurance program.
- Maintain and build client relationships on quality assurance matters.
- 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.
- 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.
- 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 clients. as needed.
- 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.
- Manage sample analyses, track results, and recommend product quarantine when necessary.
- 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.
- Monitor quality control incidents, facilitate investigations, and manage implementation of corrective actions.
- Administer appropriate actions for initiation of product recalls and adverse drug event reporting.
- Ensure all procurement, forwarding, and in-country storage and handling of both pharmaceutical and nonpharmaceutical commodities maintain quality, safety, and efficacy, as well as compliance with client regulations, working with the Global Supply Chain Unit.
- Provide ongoing management of supplier corrective and preventive action implementation, as well as complaint management procedures.
- Provide quality assurance data to the management information system, including, for approved drugs and equipment, documentation, labeling, and regulatory status.
- Maintain product master file data in the ERP system.
- Pharmacy Degree required. Degree in a laboratory science or public health desirable.
- 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 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.
- Must be authorized to work in the United States or the Netherlands.
JSI is an Equal Opportunity, Affirmative Action Employer committed to workplace diversity. We are committed to providing equal employment opportunities for all qualified applicants and employees without regard to age, race, color, national origin, ancestry, creed, religion, gender, disability, marital status, gender identity, sexual orientation, sexual preference, genetic information, political affiliation, or protected veteran status in any employment decisions. M/F/V/D
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