Since 1999, my career path allowed me to spread out my skills in multidisciplinary domains: biological sciences; quality management and audit; biomedical, environmental, and research labs. What is a good quality manager? He is an accelerator of cost savings, a facilitator of internal relationships, a promoter of continuous progress. In my opinion, a quality manager must be open-minded, he must know enough about the technicality of his product and be enough naive to let the solutions come from real actors of the progress of the company, the employees. The quality brings efficiency, speed, and longevity to a company if it’s forgotten by its users. For every company, finding the quality manager who suits it and who lasts for a long time, represents a real challenge.
IMMR is a research center specialized in GLP-FDA and GLP-OECD preclinical surgical studies for in vitro medical device testing, R&D compliance studies, histopathology, surgery training, and FDA submissions.
Develop and monitor the quality management system to keep it compliant with the FDA GLP (21CFR58), the OECD GLP (ENV/MC/CHEM(98)17), the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) certification, and the GMO (Genetically Modified Organisms) certification
Ensure that the regulatory studies comply with relevant laws, policies, and regulations
Perform inspections (audits of GLP studies, raw data, providers, internal process audits, pharmacovigilance, ...), and traceability control throughout the studies
Manage metrology and maintaining compliance of laboratory equipment
Manage X-ray/radiation safety and Health/Safety procedures
Archive management
Train the personnel in quality (GLP), x-ray, risks and safety.