Shane McBrearty

Background

About Shane McBrearty

Senior Quality professional with more than 20 years working in Pharmaceuticals, Biological and Medical Device products. Proven experience in drug product and medical device manufacture, QP release, quality assurance, regulatory inspections, regulatory affairs, vendor management, change control management, non-conformance management, internal and external auditing, clinical supplies, clinical trials, research and development quality, new product introduction, label supply, good distribution, third party manufacturing quality oversight, operational excellence, project management, aseptic manufacturing, microbiology testing, microbiology laboratory management and 18 years people management experience. Leader and contributor to cross functional teams on manufacturing, quality assurance, laboratory testing, clinical trials, research and development, packaging and supplier management. Previous roles include microbiology testing, microbiology laboratory management, aseptics quality assurance, manufacturing and aseptic filing management, clinical trial quality management, manufacturing and packaging quality assurance management. Possess skills in leadership, decision making, problem solving, technical writing, building relationships, influencing and people management.