International Drug Quality Assurance Leader

À propos du poste

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,…