Experienced in a 21CFR regulated environment. Strong background, knowledge and experience with Quality systems/issues, activities involving Pre-Approval (PAI) and FDA inspections, internal audits & contract service provider audits and quality systems supporting commercial & development products. Long history of working with inter-disciplinary teams in collaborative cross-functional settings for all phases of product development. Demonstrated communication skills with ability to influence and collaborate with internal/external clients, including partners and collaborators. Recognized for exceptional teamwork/customer service. Capable of operating independently to manage multiple projects and independently seek out resources as required.