International Drug Quality Assurance Leader

Location: Any MSF office*

Contract: Permanent contract at 100%

Starting date: Asap

Deadline to apply: 08th of September

Compensation and benefits: MSF practice is to offer the compensation and benefits package in line with the MSF entity offering the contract.

*By default, the successful candidate will be offered a contract in the MSF office, able to issue a contract, of their country of residence at the time of application. If no MSF office exists in their country of residence, the successful candidate will be expected to relocate to a country where an MSF office can issue a contract, provided the local legislation allows for that.

MSF International

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.

II. CONTEXT

One of the objectives of the pharma network is to assure the quality of medicines in MSF projects. The pharma network is mainly composed of pharmacists working in the medical departments of the operational centers (section pharmacists, pharmacy advisors), pharmacists in European Supply Centres (ESC), pharmacists in the Access Campaign / Access to Products for Healthcare and regional/intersectional pharmacists.

Coordination of this network is done by the International Pharmacist Coordinator (IPC) who has a permanent position within the International Office.

Main activities of the International Pharmaceutical Coordination team (from an International QA perspective) are:

• To maintain the coherence of the MSF pharma network, where the Drugs QA Leader focuses on the quality related ESC groups composed not only of pharmacists, but also ESC buyers.

• To coordinate the implementation of the MSF Qualification Scheme for international procurement and all related activities with the support of external experts, when needed. This is a key responsibility of the Drugs QA Leader.

• To facilitate and ensure that common specifications and procedures are implemented and used in all sections and ESCs – the Drugs QA Leader focuses on the coordination within the ESCs.

• To participate to external networks/meetings with other key international actors (UNICEF, WHO, ICRC…) sharing the objectives to improve quality of medicines on the international market. The Drugs QA Leader builds and maintains external collaborations linked to quality related topics.

III. PURPOSE OF THE JOB

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.

IV. KEY ACCOUNTABILITIES

The extent to which a job is answerable for actions and their consequences. It describes the area and nature of impact of the job on the organisation.

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. Additional ad hoc support may be provided in other specific TVs for specific country contexts.

• Briefs and coachs 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.

V. PROBLEM-SOLVING

Challenges and decisions that the job faces to achieve the accountabilities:

• 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.

VI. DIMENSIONS

Facts / figures relevant to the scale of the job e.g.:

• 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 Complaint

Know-how needed to effectively perform in the role:

• Solid technical background on Quality Assurance and Goods manufacturing practices.

• Well-founded risk assessment skills.

• Strong MSF operational experience.

Practical / technical knowledge

• Master's degree in Pharmacy

• Minimum 5 years of experience. At least 2 years in MSF

• Mandatory experience in quality assurance. Good knowledge of MSF quality and procurement policies.

Planning and organising

• 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.

Communicating and influencing

• Able to represent MSF in external meetings.

• Highly diplomatic.

• Capacity to persuade and motivate.

• Team player.

• Anticipates and resolves conflicts by pursuing mutually agreeable solutions.

Practical requirements

• Fluent in English, French a plus.

• Regular travels, mainly in Europe.

Only shortlisted candidates will be contacted.

At MSF, we are committed to an inclusive culture that encourages and supports the diverse voices of our employees. We welcome applications from individuals of all genders, ages, sexual orientations, nationalities, races, religions, beliefs, ability status, and all other diversity characteristics.

MSF is committed to preventing abuse, inappropriate behaviour, lack of integrity and financial misconduct in its work and care spaces. MSF expects all staff to share this commitment and promote an environment where abuse and misconduct is not tolerated.

We are committed to removing barriers for people with specific accessibility needs. If you need an adjustment to the recruitment process to be considered for the role, please let us know from the beginning of the selection process.

Note: All offers of employment will be subject to reference checks and to appropriate screening checks. By submitting an application, the job applicant confirms his/her/their understanding of these recruitment procedures.