Abbott Senior Associate Quality & Regulatory Compliance in Zaventem, Belgium
We are recruiting a Senior Associate Quality & Regulatory Compliance EMEA to be based in our offices in Zaventem.
The purpose of the job is to assist the Quality and Regulatory Compliance Manager in the implementation and roll-out of QA/RC governance alignment and improvement projects throughout the International Commercial Abbott Medical entities.
Your roles and responsibilities include:
Act as Project Leader for alignment and integration projects as defined in the Commercial Quality and Regulatory Compliance Business Alliance Quality Plan.
Cooperate with regional commercial QA/RC teams on alignment and integration projects.
Define activities and develop project plans for major quality improvement projects (Training, Supplier Management, Distributor Management, Document Control, etc.)
Escalate and communicate Regulatory Compliance issues in a timely and effective manner to the Quality and Regulatory Compliance Manager.
Liaise with stakeholders in cross-divisional Improvement and Alignment projects.
Support all company initiatives as identified by management in support of Quality Management System improvement and alignment initiatives.
Provide trainings to regional commercial QA/RC teams on Quality System Integration Activities
Monitor compliance to appropriate regulatory standards.
Support Quality control processes within the international commercial QA/RC regions: KPI monitoring, input to Management Review, CAPA, Quality Plans, Doc Control, etc.
Identify improvement needs in regional quality systems and define actions and project plans to implement those improvement needs.
Initiate, revise or update Quality System Procedures affecting the commercial international quality organizations.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance
Develop and implement training programs in cooperation with regional commercial QA/RC teams on major changes and new processes in international Quality Management Systems.
Write periodic reports to communicate status of commercial QA/RC related projects, goals and objectives to Management.
Performs other related duties and responsibilities, on occasion, as assigned.
University Degree, Graduated in sciences (Biomedical, Engineering, Pharmacy, Paramedics, etc.)
5 – 10 years quality supervisory experience in life sciences industry.
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work effectively within a team in a fast-paced changing environment.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multi-tasks, prioritizes and meets deadlines in timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Ability to travel approximately 25% internationally.
In depth knowledge of international Regulations (MDR, FDA, …) and Standards (ISO 13485, …)
Ability to effectively troubleshoot issues in quality related systems and processes
Good working knowledge of English
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com