Customer-driven Executive Level Quality Assurance/Regulatory Affairs/Clinical/Operations Leader with extensive experience leading, developing, and implementing quality and regulatory departments , production, and long term strategies under U.S. and international regulations within the pharmaceutical, combination, animal health, biotechnology, and medical device industries. Accomplished transformational leader, proven strategist, skilled communicator, team builder, and adept negotiator who blends expertise in facility, operations, engineering, safety, regulatory affairs, and quality management with exceptional skills in business development.