A world leader in the field of in vitro diagnostics for over 55 years, bioM
erieux conceives, develops, produces and markets diagnostics solutions
(systems, reagents, software and services) intended for clinical and
industrial applications, which determine the origin of a disease or a
contamination to improve the health of patients and insure consumer safety.
bioMerieux is present in 44 countries and serves more than 160 countries with
the support of a large network of distributors. Its corporate headquarters are
located in Marcy l'Étoile, near Lyon, in France.Joining bioMerieux is choosing
to be a part of an innovative company with a long term vision, committed to
the service of public health and carried out with a human-centered corporate
culture. Our Company offers numerous opportunities for professional
development. You want to help save lives across the globe? Join the 13,000
employees of bioMerieux!
Accountable for the implementation and compliance of the Quality Management
System with applicable requirements (ISO standard 9001, Corporate
requirements, Regulatory compliance, Local Regulation) in order to ensure that
customer expectations are met. Supports and supervises the process owners to
ensure the implementation- and continuous improvement of the Quality
Management SystemAccountable for the implementation and compliance of the
Quality Management System with applicable requirements (ISO standard 9001,
Corporate requirements, Regulatory compliance, Local Regulation) in order to
ensure that customer expectations are met. Supports and supervises the process
owners to ensure the implementation- and continuous improvement of the Quality
Management System.
What will be your mission?
*
Responsible for the implementation of the of the corporate quality policy.
Responsible for the definition and implementation of quality objectives for
the subsidiary aligned with Corporate and Cluster quality objectives.
* Identifies quality training needs, defines quality training plan and ensures appropriate quality training of local staff, including Quality Inductions.
* Accountable and responsible for document and record control, including the distribution of Corporate quality documents and the implementation of the resulting applicable requirements. Contributes to the improvement of the cluster quality system for instance by participating to cluster projects and executing other tasks dictated by the Regional Quality Leader.
* Accountable to manage and execute critical supplier audits, external audits, distributors audit and internal audits to ensure inspection readiness, with support of internal auditors. Accountable and responsible for the execution of the Management reviews and outputs, Change Management, CAPA and Supplier approval processes for the subsidiary - including assuring the continued supplier qualification.
* Accountable to ensure that an effective complaint handling process is in place. Accountable and responsible to manage customer satisfaction surveys and follow up as required.
* Accountable to ensure the compliance of Distributors and provide support on Training and critical processes.
* Ensure that Quality Management System Review is scheduled for the subsidiary: 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.
* Manage hierarchically the quality and regulatory team within the cluster
* Collaborate within Africa quality team in order to share and implement good practices.
* Be the Vigilance contact for Competent authorities (CA) in the subsidiary and thus responsible for the timely reporting of Field Safety corrective actions and incidents. Responding in a timely manner to the requests from Competent authorities, customers, third parties regarding regulatory compliance.
* Accountable for the implementation of Field Corrective Actions (FCA/FSCA/MAR/PSS/PRS) by working with and providing support to the Customer Service team.
* Accountable and responsible to monitor the local regulatory environment and reporting Vigilance KPIs to Management.
* Accountable for taking local Potentially Reportable Event decisions and ensuring that vigilance software's and tools are up to date.
* Accountable for Regulatory Watch, Registration activities, follow up Questions from Competent Authorities.
* Management of a Quality team in the subsidiary. Work on the local organization to make sure that resources necessary to accomplish the objectives are raised to General Manager and Africa Region Quality Manager.
* In the Africa Quality team, lead Quality /Compliance projects within Africa, with the others clusters, to improve the level of compliance with the Region.
* Have a risk based approach, to identify the risks and implement preventive actions to mitigate the risks
* Develop Partnership with internal / external Stakeholders.
* Maintain the right Quality and Vigilance level in the Clusters.
* Enhance the Quality Mindset within the Business organization.
Who are you?
*
Quality , Regulatory studies or Background in the field
* Scientific background in biology, chemistry.
* At least 5 years' experience in life sciences, pharma, food, Medical devices or IVD company
* Good leadership and communication skills; ability to motivate and lead projects
* Ability to analyze and use data to drive process improvements.
* Experience in participation in the management of regulatory audits (i.e. ISO 9001, ISO 14001, FDA etc.);
* Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR etc.).
* Management skills.
Working at bioMerieux means being involved long term with a pioneering,
visionary and constantly growing company that allows its employees to live a
stimulating and inspiring experience in a fulfilling work environment
Our internal mobility policy offers numerous opportunities for each of our 13
000 employees to blossom throughout their career, while respecting each
employee's individual talents as well as their personal and professional
development.
At bioMerieux, over 200 professions - both scientific and non-scientific -
offer our employees the opportunity to broaden their fields of expertise and
develop cross-functional careers. We provide a rewarding experience in an
international company that brings together talents from diverse backgrounds,
thus fostering a daily aspiration to go beyond the limits.
Helping improve public health around in the world : our mission gives purpose
to every profession practiced within the company.
bioMerieux is an Equal Opportunity, Affirmative Action Employer.
M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.