Expertise: Quality, Audits, GCP
Sheila Gwizdak has over 25 years of experience in the biotechnology and pharmaceutical industry. Her career has focused on quality, process improvement, and training including the execution of corporate and department-level quality assurance initiatives such as developing and improving Quality Management Systems, compliance gap analyses and remediation, inspection readiness, audits, and training. Sheila also has specific experience in clinical and quality risk management, and inspection readiness activities (FDA, EMA, MHRA, and PMDA) including storyboard development, coaching, and conducting mock inspections.
Before joining Halloran, Sheila was a director at Alexion where she supported the development and implementation of a quality management framework that included the standardization of procedures, systems, training, and processes. Before joining Alexion, Sheila held a series of progressive positions with Pfizer, Inc. in clinical quality, operations, and training.