Description de l'emploi
The Quality Assurance Manager is responsible for creating and supporting a Quality culture across IBA by driving compliance activities through product life cycle. This includes driving the Quality and Compliance activities for the Quality Management System (QMS) implementation, audits, complaints, CAPA, continuous improvement.
Responsibilities & duties:
• Support management and maintenance of the Quality Management System. Ensure it is in place and it is recognized, understood and maintained across the company.
• Communicate internally on the Quality Management System implementation and review progress
• Lead quality to ensure continuous improvement and compliance of the Quality Management System
• Develop and Monitor quality metrics to assess the Quality Management implementation and alert on deviations. Escalate when necessary
• Ensure that GMP/Quality Standards/Procedure/Methods/Guidelines are applied
• Ensure / manage that all compliance audits are properly conducted and completed.
• Lead quality efforts in corporate development of analytical methods.
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implication regarding these changes.
• Provide quality guidance to process improvement projects and programs
- University Degree
- A minimum of 10 years of experience in Quality in ISO 9001 company(ies) (preferably having customers in pharma or medical devices industries)
- High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
- Excellent level of oral & written communication skills enabling to act as a facilitator and/or educator with strong leadership skills.
- Proficient English
- Adaptable and willing to take on multiple new tasks and responsibilities
- Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
- Process orientated, Logical, analytical, meticulous, highly organized and able to analyze data & implement solutions.
公司IBA : opening new ways in the fight against cancer.
IBA is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The Company’s expertise lies in the development of next generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully integrated IntegraLab® radiopharmacy system, and Dosimetry advanced solutions for Quality Assurance of medical equipment and increased patient safety.
Headquartered in Belgium and employing more than 1,500 people worldwide, IBA currently has installed systems across Europe and the US and is expanding into emerging markets.
The Company is focused on providing solutions in the fight against cancer.
聘用意向书IBA offers you the opportunity to realize great achievements in the fight against cancer. Our employees are perceived as passionate, pragmatic and result oriented people dedicated to develop leading edge technologies to protect, enhance and save lives !
If you are stimulated by multicultural challenges and willing to travel, we offer you the opportunity to join a team of more than 35 nationalities working on more than 40 different sites on 3 continents.
IBA offers you a competitive performance based compensation package and a flexible work environment. You have real possibilities to evolve within IBA's worldwide, leading organization and to create your own career path, supported by training programs to acquire new skills and ensure they stay sharp.
As an Equal Opportunity Employer IBA is committed to a diverse workforce.