Hubert Krawczyk
About Hubert Krawczyk
Hubert Krawczyk is a Quality Manager R and D at Bristol-myers Squibb and a Manager of Quality Assurance at Hewlett-packard, with extensive experience in clinical process management and regulatory inspection within GxPs.
Title
Hubert Krawczyk holds the position of Quality Manager R and D; Ceet at Bristol-myers Squibb in New Jersey, United States. He is also the Manager of Quality Assurance at Hewlett-Packard in San Jose, California, United States.
Quality Manager Career
Hubert Krawczyk has a well-established career in quality management, currently serving roles at Hewlett-Packard and Bristol-myers Squibb. His experience includes managing cross-cultural teams to streamline clinical processes and executing vendor qualification and management within GCP, GCLP, and GDP frameworks.
Expertise in Regulatory Inspection Management
Hubert Krawczyk specializes in regulatory agency inspection management within GxPs. His proficiency encompasses conducting root cause analysis, gap analysis, and Failure Mode and Effects Analysis (FMEA). He is highly skilled in auditing clinical investigational sites, vendors, and R&D systems.
International Clinical Research Experience
With significant experience in managing multi-country clinical research programs, Hubert Krawczyk is adept at expanding operations into new markets. He has a robust background in early clinical development and is proficient in creating and reviewing standard operating procedures (SOPs) for clinical site monitoring and quality assurance.
Vendor Qualification and Management
Hubert Krawczyk has extensive expertise in vendor qualification and management within the realms of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and Good Distribution Practice (GDP). His comprehensive approach ensures adherence to regulatory standards and optimizes clinical processes.