International Laboratory QA specialist 50% / SPINCO Unidata Data Steward 20%

Location: Any MSF office*

Contract: permanent at 70%

Starting date: asap

Deadline to apply: 05.01.2025

Compensation and benefits: MSF practice is to offer the C&B package current in the MSF entity establishing the contract.

*By default, the successful candidate will be offered a contract in the MSF office of their country of residence at the time of application.

I. 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, 27 associations and other 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. POSITION BACKGROUND

MSF, as a humanitarian organization, is committed to providing its projects with quality- assured medical products, including medical devices and IVDs. According to its QA policy, MSF has developed a systematic way to ensure the quality of medical devices and IVD purchased by the MSF supply centers. This involves a product/manufacturer evaluation process according to recognized international standards. Most critical rapid diagnostic tests of interest for MSF are eligible for WHO prequalification, but laboratory items used by MSF also cover a wide range of products such as laboratory reagents, consumables and equipment, most being outside of the WHO prequalification scope. Besides, since most products sourced by MSF are CE marked, the transition from the IVD directive to the IVD regulation impacts the MSF QA review process and the availability of MSF products of interest. In 2024, IVDs were identified as a priority by GPU and a category buyer was appointed for this products category, to cope with the market instability due to the IVDR leading to product discontinuation, to put extra efforts on sourcing and suppliers’ negotiations and monitoring. As a result, for both routine and contextual reasons, the QA workload for laboratory products increased over the past years.

The Coordination and Source of Product Information (SPINCO) was created to maintain consistency in the choice of medical and non-medical articles between MSF sections in order to improve MSF interventions, while taking into account field realities.

SPINCO delivers a central source of trusted product information that enables product quality and visibility for better quality of care, improves the supply chain performance and increases the overall interoperability whilst reducing duplication of effort. The objective is to make the product information available and visible for the whole MSF supply chain and maintain the data quality of the products and descriptions in UniData for medical articles.

By guaranteeing the quality of the information and the respect of the procedures, the datasteward acts as a facilitator taking into account the needs of the different actors of ESC’s, OC’s and field missions.

III. PLACE IN THE ORGANISATION

The Laboratory QA specialist and SPINCO Unidata Data Stewart is part of the IO QA coordination and SPINCO team of MSF International. He/she reports jointly to the International QA Medical Device Coordinator (IMDC), Elsa Tran, and SPINCO Data Stewart Coordinator, Vinciane Cruyt, and works closely with key staff in MSF supply centres (QA referents), in the IO QA coordination and SPINCO teams (IO QA specialists and SPINCO data stewards) and with the GPU category buyer for laboratory products. He/she also collaborates with Operational Centres (lab advisors and OC QA referents) and the Laboratory WG leader and advisor.

IV. OBJECTIVES OF THE POSITION

Under the supervision of the IMDC, the first main objective is of the position to ensure that the quality-assured laboratory items, are provided to MSF projects, by making available reliable and verified technical, quality and regulatory information to the ESC. Those items must meet the operational needs, defined by the laboratory working group in terms of usability and performance. In practice, this means to coordinate the documentation collection in the MD repository and the products quality reviews in Uniquality, and to maintain this information up-to-date in the different MSF database. The position also provides an operational support to the supply strategy defined by the GPU category buyer in charge of laboratory products.

Under supervision of the SPINCO medical coordinator, the second main objective of the position is to edit and to improve the quality of the MSF medical catalogues with the follow-up of the creation of new standard articles, starting from the request form up to the publication of the technical sheet in the catalogue. This means to make the product information available and visible for the whole MSF supply chain and improve and maintain the data quality of the products and descriptions in UniData for laboratory articles. By guaranteeing the quality of the information and the respect of the procedures, the datasteward acts as a facilitator between the needs of the different actors of ESC’s, OC’s and field missions.

V. MAIN RESPONSIBILITIES

Laboratory QA specialist role, reporting to the IMDC

• Product assessment:

o Provide regulatory and quality inputs to the GPU category buyer in charge of market intelligence and of the relationship with suppliers, and the intersectional laboratory advisor performing market reviews

o Implement the international qualification scheme for IVD:

1. Organize the quality assessment of diagnostics and laboratory articles according to the product distribution agreed among ESC QA referents

2. Support the ESC QA referents in performing quality reviews in UniQuality

3. Support the ESC QA referents in managing documents in the Medical Device Repository

4. Act as second QR reviewer according to the qualification scheme

5. Act as first reviewer for some QR depending on the ESC QA referents workload

• Quality of information monitoring:

o Collaborate with the Uniquality data steward to define KPIs in Uniquality and the MD repository for laboratory items

o Ensure the consistency of information between Unidata and Uniquality and update or correct mistake as needed in collaboration with the ESC QA referents

• Quality complaint/batch recall management:

o Coordinate the management of quality complaints/batch recalls for laboratory items between the ESC QA referents, the lab advisors and OC QA referents according to the harmonized international SOP, with the support of the IMDC

• Regulatory intelligence:

o Monitor the global regulatory environment of IVD and prepare regulatory brief for internal communication to the relevant stakeholders

o Follow-up the implementation of the IVDR to anticipate product discontinuation and propose adaptation of the qualification scheme and database accordingly

• Sustainability:

o Contribute to the ‘Rethinking the use of disposable medical devices and IVD’ initative for the identification of greener IVD alternatives and the definition of more sustainable technical specifications while respecting the QA policy

Collaboration with the LWG, double reporting

• Be the focal point for the intersectional laboratory advisor to follow up the request forms issued by the LWG for new laboratory articles, changes or deletions and liaise with the ESC QA referents

• Support the item standardization process by providing information for the Med Dir decision and updating Unidata accordingly

UniData data steward role, reporting to the SPINCO data stewart coordinator

• Create, formalize, enforce and improve rules for the creation of laboratory articles, codes, labels and descriptions according the data governance system, with the input of OC referents and ESC data-owners.

• Create new laboratory standard and non standard products codes in UniData

• Answer and follow-up on outstanding questions/feedbacks regarding laboratory articles with the relevant referents and adapt the codes, labels and/or codification rules when needed.

• Be the focal point for other SPINCO datastewards and OC lab WG members for any request of code creation or information from UniData concerning laboratory articles.

• Review and check the quality of the laboratory Master Data once or twice a year. Assure that corrections in codes, labels and other attributes are made when needed to guarantee quality and identify the missing descriptions.

• Create, supervise and/or validate that standard or non standard article descriptions (technical sheets) with the help of the international working/contact group members

• Follow-up on outstanding questions or feedbacks regarding the descriptions with relevant referents.

• Medical Laboratory technologist degree or pharmacist degree with experience in regulatory affairs and IVD or medical laboratories

• Experience (more than 2 years) in similar positions

• MSF experience is an asset

• Knowledge of global regulatory pathways for IVD, WHO prequalification processes for IVDs, and ISO 13485 standard is a strong asset

• Attention to detail is a must

• Good analytical and problem-solving skills

• Ability to communicate with stakeholders with various background

• Ability to work and report independently

• Proficient in English, French is an asset

Specific Requirements:

• Knowledge the MSF product catalogue and database (Unicat, Unidata, Uniquality) is an asset

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.