[Hiring] International Drug Quality Assurance Leader @MSF International

Role Description

Lead the MSF Drug Quality Assurance activities in order to identify new quality sources of drug supply, consolidate the MSF drug QA system to ensure quality, safe and efficacious medicines are used by MSF patients and achieve a coordinated approach towards quality medicines within the ESCs to increase synergies and gains efficiency, as well as monitor international regulatory developments and dynamics that may have an impact on MSF.

Qualifications

• Master's degree in Pharmacy
• Minimum 5 years of experience, with at least 2 years in MSF
• Mandatory experience in quality assurance
• Good knowledge of MSF quality and procurement policies

Requirements

• Solid technical background on Quality Assurance and Goods manufacturing practices
• Well-founded risk assessment skills
• Strong MSF operational experience
• Outstanding organization skills, maturity and judgement to prioritize
• Capacity to work and report independently
• Capacity to synthesize complex information
• Able to handle and adapt to changing priorities
• Gathers relevant information before making a decision
• Fluent in English; French is a plus
• Regular travels, mainly in Europe

Benefits

• Compensation and benefits package in line with the MSF entity offering the contract

Company Description

Médecins Sans Frontières (MSF) is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters. MSF offers assistance to people based only on need and irrespective of race, religion, gender or political affiliation.

MSF International is the legal entity that binds MSF’s 24 sections, 28 associations and 19 branch offices together. Registered in Switzerland, MSF International provides coordination, information and support to the MSF Movement, as well as implements international projects and initiatives as requested.

Key Accountabilities

• Develops clear goals that are consistent with agreed strategies in terms of identifying, selecting and adding to MSF database repository
• Coordinates and leads the ESCs (QAs and buyers) in all pharmaceutical aspects linked to the search of sources, selection and use of essential medicines identified as priority
• Coordinates with SPINCO and working groups for any inclusion or changes to MSF catalogues and coordinates the QA/supply check related to new medicines requests
• Identifies strategic opportunities and risks to manage and continue to develop the MSF Quality Management System (QMS)
• Responsible for the creation and revision of the MSF Quality Management System for medicines
• Ensures proper updating and storage and communicates changes to the relevant pharmacists (IMES, IPC, pharma network)
• Organizes the section pharmacists’ annual product dossier audit on the implementation of MSF Qualification Scheme carried out together with the ESCs
• Following audits of MSF QA system, is responsible for CAPA (corrective and preventive actions) and implementation of the recommendations linked to his/her scope of competences
• Writes the annual report of the QA activities (products approved/not approved/exceptionally approved/products monitored and variations assessed, etc.)
• Acts as QA lead for drugs as delegated by the OCs
• Coordinates product qualification activities within the IPC team: IMES meetings and follow-up of the action points, assigns and monitors dossier assessment progress, final review
• Ensures approval of product dossiers (including variations & monitoring) and Declaration of Equivalence (DoE)
• Maintains quality reviews in UniQuality for the following approval routes: MSF qualification, WHO PQ and DOEs (to SRAs, to WHO PQ and to PSS)
• Manages external experts for the assessment of therapeutic equivalence
• Performs risk assessments together with the IPC to facilitate decision-making of DirMed platform
• Prepares documentation for DirMeds decision on exceptional validations, route M, of dossiers
• Performs the annual risk analysis for prioritization of audits, TVs and MVs planning and supports the IPC in the elaboration of the plan
• Participates to manufacturing site audits and performs technical/monitoring visits as per plan
• Briefs and coaches newcomers (section pharmacists, intersectional, AC/APH or ESC pharmacists) on MSF QMS, Qualification Scheme and product dossier assessments
• Provides technical guidance and support to the ESCs pharmacists on QA and procurement
• Key focal point for Working groups (including malaria WG), to ensure they have regular and efficient support
• Is the MSF focal point for antimalarial medicines internally (SPs, ESCs, AC) and externally (manufacturers, ext. actors)
• Participates in the work of the malaria contact group, including: update on latest developments in treatments, international recommendations and initiatives; availability and potential procurement problems
• Updates technical information in UniQuality anti-malaria medicines reviews
• Revises regularly with the working groups (malaria contact group or others) the list of priority medicines, for which quality sources need to be identified for MSF
• Acts as focal point with working groups with no dedicated pharmacist in any pharma related issue
• Plays a strategic role in the broader move in topics linked to supply, procurement, etc.
• Contributes to the definition and implementation of the strategy and plan of action of the Pharma Network
• Contributes to the Supply Transformational topics strategy, particularly but not only, to the GPU specific priorities and to the regional hubs set-up and development
• Guides ESCs to achieve a coordinated approach to access to quality medicines
• Guides technical developments of the UniQuality tool
• Liaise with WatSans to ensure updated information on waste management is available for all medicines, by providing technical input on the nature of each molecule
• Supports the IPC on specific requests or dossiers

Problem-Solving

• Autonomy to think and act
• Risk analysis and decision making
• Complex environment: coordinating with 3 ESC QAs, their managers, the ESC buyers, the Regulatory Affairs pharmacists, OC pharmacists and the IO team, pharma, supply/procurement
• First contact with all the WG, OCs and ESCs, related to the DirMed platform

Dimensions

• ESC and Disease Focused pharmacists coordinating and leading: 9 QAs
• Uniquality: 6,100 Quality Reviews (sources) for Drugs
• Quality Management System: 112 active SOPs to manage
• 539 standard and non-standard medicines to ensure quality source for
• 35 annual number of Quality Complaints