Cecelia Smiley-Adams

Cecelia Smiley-Adams has extensive experience in the pharmaceutical and biotechnology industry. Their most recent role is as a Senior Quality Compliance Manager at Capricor Therapeutics, Inc. where they began in May 2022. Prior to that, they worked as an eTMF Document Specialist at Zymeworks Inc. from September 2021 to February 2023. Cecelia also held the position of Senior Regulatory Coordinator at Medix™ from February to April 2021.

Before that, Cecelia worked as a Clinical Trial Associate at ExecuPharm from March 2020 to February 2021 and at Aerotek from May 2019 to March 2020, providing CTA support for multiple oncology clinical trials and conducting regulatory monitoring.

From 2015 to 2019, they served as a Clinical Documentation Control Manager at CTI BioPharma, where they managed Trial Master Files and ensured compliance with FDA/ICH regulations. Prior to that, they were a Regulatory Compliance/QA Manager at HealthFirst, a Henry Schein subsidiary company, from August 2010 to January 2015, overseeing regulatory compliance and quality assurance for a medical device manufacturer and wholesale drug distributor.

Cecelia also has experience as a Regulatory Compliance Specialist at Gilead Sciences from June 2008 to June 2010, where they conducted GCP audits and ensured regulatory compliance. Cecelia worked as a Quality Assurance/Regulatory Specialist at Sonus Pharmaceuticals from May 2006 to June 2008, handling regulatory documentation and addressing discrepancies.

Their earliest role was as a 21 CFR Part 11 Validation Coordinator at Amgen (contract position) from March 2004 to May 2006, supporting a compliance project and training staff on validation systems. Overall, Cecelia Smiley-Adams has a strong background in regulatory compliance, quality assurance, and clinical trial support.

Cecelia Smiley-Adams obtained an Associate's degree from Green River College, where they studied an unspecified field from 2001 to 2003. Cecelia then pursued a Bachelor's degree in BA from the University of Washington from 2003 to 2005. Later, in 2007 to 2008, they attended the University of Washington again and completed a Certificate program in Biomedical Regulatory Compliance.