Elaine Sims
Vice President Quality Assurance and Regulatory Affairs @Legacy Pharmaceutical Packaging, Llc
Signup · Get unlimited contacts
WORK HISTORY
Vice President Quality Assurance and Regulatory Affairs @Legacy Pharmaceutical Packaging, Llc
Earth City, MO, US
ABOUT ELAINE SIMS
As the Vice President of Quality Assurance and Regulatory Affairs at Legacy Pharmaceutical Packaging, LLC, I have over 39 years of experience in ensuring compliance and quality excellence in the pharmaceutical industry. Legacy is a contract pharmaceutical packaging company that serves various health sectors, including generics, OTC, and nutraceuticals.My core competencies include FDA GMP, validation, SOP, quality metrics, CAPA, and investigation resolution. I lead the quality and regulatory functions at Legacy, overseeing the development and implementation of a robust quality management system, fostering a culture of quality and continuous improvement, and collaborating with internal and external stakeholders. Some of my recent achievements include achieving a zero-483 inspection from the FDA, reducing the cycle time of investigations by 50%, and securing a large contract with a major pharmaceutical client. My mission is to enhance the quality standards and performance of Legacy and the pharmaceutical industry as a whole.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.