A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies.
Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health.
bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety.
Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.
We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.
Primary Purpose and Overall Objective of the Job :
Ensure an efficient cluster QMS is established that is in compliance with Corporate and external requirements (e.g. applicable standards and regulations).
Standardize and harmonize processes within the cluster as far as possible.
Main Accountabilities :
Define necessary organization in the cluster.
Ensure the implementation of the corporate quality policy on sub level.
Ensure the implementation of the corporate quality objectives (communicate, share, contribute to Corporate Quality Objectives)
Define SMART quality objectives for the cluster together with local QMR and GM / cluster VP and standardize inside the cluster.
Select new QMR in case of open position and develop quality competencies for local QMRs
Make sure that resources necessary to accomplish the objectives are raised to GM / Cluster VP.
Provide expert advice and support to the QMRs within the cluster. If specific knowledge is needed, ensure that appropriate support will be provided.
Help implement new requirements resulting from Corporate documentation, if needed.
Define and ensure appropriate quality training for the subs of the cluster. Make sure quality training needs are identified, quality training plan is established and follow-up.
Ensure that Quality Management System Review is scheduled for each sub of the cluster
Organize and coordinate the collection of data from subs QMR and prepare the Management Review. Analyze the data, summarize them, prepare the output from the Management Review for approval.
Ensure that relevant KPI's are defined for the subs. Consolidate KPI's at cluster level. Define relevant action plans linked with the level of the KPIs and follow-up.
Make sure that audit needs on sub level are identified, that internal and supplier audit schedules are established and implemented and that appropriate resources are allocated (including qualification of internal auditors).
Manage hierarchically the quality and regulatory team within the cluster
Collaborate within the EMEA quality team in order to share and implement good practices
Scientific background in biology, chemistry
5 years experience in life sciences, pharma, food, Medical devices or IVD company as RA and / or QA manager
Good leadership and communication skills
Experience in participation in the management of regulatory audits (i.e. ISO 9001, ISO 14001, OHSAS, FDA, EPA, OSHA, etc.);
Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.
g. ISO, QSR, UL, CSA, VDE, etc.).
Scope and Resources Accountability, typical Performance Indicators :
Africa cluster : subsidiaries, distributors and offices QMS
Quality score card KPIs, local KPIs. Inspection readiness completion on time
Coordination and follow up of the Field actions and vigilance KPIs with local vigilance contacts in Africa