Quality Assurance and Regulatory Manager At John Snow

The Partnership for Supply Chain Management (PFSCM) strengthens, develops, and manages secure, reliable, cost-effective, and sustainable global supply chains to improve the health and well-being of people in low- and middle-income countries through increased access to quality and affordable health products. We help governments, non-profit organizations, and humanitarian agencies to achieve their public health goals through cost-saving procurement, efficient logistics, pharma-grade storage, last-mile delivery solutions, and real-time data tracking. PFSCM demonstrates its commitment to customer satisfaction and service excellence by upholding an ISO 9001:2015 certified Quality Management System that underpins all our processes, systems, and services.
PFSCM is a subsidiary of one of the leading international health consultancy organizations in the US — JSI Research & Training Institute, Inc. (JSI). In addition to our project management headquarters in Washington D.C., in the U.S., and our operational facility in Woerden, in the Netherlands, we have access to 50 other JSI offices around the world.
Within PFSCM’s global structure, approximately 90 seconded staff members from more than 35 countries contribute to the impact achieved through PFSCM’s services. PFSCM’s diversity of thought and culture allows us to engage fully with our clients and each other. We believe we can achieve our mission by upholding our purpose- and results-driven cultural style. We do this by creating an environment where staff can demonstrate our cultural values of collaboration, learning, proactivity, problem-solving, and outcome orientation on a daily basis.

RESPONSIBILITIES

The Quality Assurance & Regulatory Manager (QARM) is responsible for managing PFSCM’s Quality Assurance and Regulatory (QARU) Unit and its associated services and processes working independently from other operational units to provide effective quality assurance (QA) and regulatory oversight in all PFSCM projects. The QARM provides leadership and oversight to support PFSCM’s QA staff in the development, implementation, maintenance, and improvement of PFSCM QA and Regulatory processes in accordance with international quality standards, best practices, and client QA and regulatory requirements.
The QARM is expected to ensure quality compliance in the procurement of pharmaceuticals, in-vitro diagnostics, medical devices, and other health products for focused low and middle-income countries. The QARM will provide cross-cutting technical guidance and insights on QA and regulatory matters to internal stakeholders.
The QARM also assists in developing quality compliance and risk mitigation strategies, seeks synergies across units, and reaches out to other technical and scientific specialists as necessary. The QARM is the key contact to ensure ongoing quality assurance and regulatory-related processes under PFSCM are aligned with that of other units as necessary.
The QARM is responsible for managing the vendor prequalification quality audit program based on current GMP/GSDP guidelines and represent PFSCM’s QA policies and standards with clients and industry-related occasions.
The QARM directs and manages the QARU and is responsible for Unit performance and staff management, development, support, and coaching of the officers.
Specific responsibilities

Lead and manage PFSCM’s global quality assurance program and ensure that the organization is operating in compliance with regulatory requirements and industry guidelines, including leading the review of PFSCM quality assurance policies, QMS documents and global regulatory guidance to ensure alignment with regulatory requirements and harmonization with QA policies of donors, clients and other recognized institutions.
Develop strategy and processes around quality audits of suppliers in accordance with international ISO standards, WHO MQAS and Good Manufacturing, Storage & Distribution Practices Guidelines.
Build and maintain client relationships on quality assurance and regulatory matters with appropriate internal and external stakeholders.
Support the Chief Quality & Risk Officer as a team leader in PMO-NL in maintaining and improving the quality culture through relevant and specific initiatives.
Support the design and implementation of knowledge management systems to effectively organize and share, amongst stakeholders, information on QA regulations and standards to inform PFSCM policy formulation and process improvements. Prepare internal reports and/or publish findings, as appropriate.
Drive continuous improvement activities and develop risk mitigation strategies to ensure that all health products supplied by PFSCM are procured, stored, and shipped in accordance with applicable policies and standards of PFSCM and that of the Client. Monitor internal trends, proactively identify potential quality problems and risks along the supply chain and advise on mitigation measures.
Manage PFSCM’s supplier and product prequalification programs and related activities, in close collaboration with PFSCM’s Strategic Supply Chain Unit, including master data management and maintenance of documentation related to approvals. Coordinate PFSCM’s quality control sampling and testing program including selection and contracting of prequalified service providers.
Review and approve chemical analysis and physical inspection reports of products for compliance with specifications/standards and make recommendations on product disposition (rejection or acceptance).
Lead investigation of quality-related incidents and complaints to facilitate root cause analysis and implementation of appropriate corrective and preventive actions, including the administration of appropriate actions for product recalls, field safety notices and adverse drug event reporting.
Provide technical assistance and consultation on QA and regulatory matters to all PFSCM units, as requested; including technical guidance on shipment of temperature-sensitive products i.e. use of temperature loggers to mitigate risks of temperature excursions and approving temperature logger reports.
Support implementation of QMS processes such as quality audits, management review, and risk management.
Contribute to PFSCM’s business development efforts as requested.
Lead and manage the unit in full accordance with PFSCMs Quality Management System, policies, standard operating procedures, and work instructions in collaboration with the senior team members.
Manage staff and unit performance at a global level and individual level and provide ongoing feedback.
Develop and maintain an on-boarding training program and regular refresher training for internal teams, new hires, and external stakeholders for alignment on processes and SOPs.

QUALIFICATIONS

Professional and Technical Knowledge

Pharmacy Degree required. Degree in a laboratory science or public health desirable.
10+ 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.
7+ years’ experience in pharmaceutical analysis, and product quality assessments and standards.
5+ years’ experience in product regulation.
5+ years’ experience with Medical Device class I, II and III products and their accessories, registration, authorization and certification requirements.
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.
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 Netherlands.
Leadership/Strategic Thinking
Strong leadership and proven ability to recruit, direct, train, and manage a team of personnel.
Strong action management including the ability to manage project in the most cost efficient manner; resourcefulness, initiative, maturity of judgement, and the ability to make sound decisions under pressing conditions.
Interpersonal skills/Communication
Strong interpersonal skills and an ability to work across disciplines and in diverse locations internationally.
Excellent written and oral communication skills. English fluency required, additional international business language fluency is preferable.
Continuous improvement/Innovative
Experience with continuous improvement initiatives and change management activities.
Priority Setting, Problem Solving, & Detail Orientation
Strong analytical and problem-solving skills at a senior level with major international manufacturing companies.**