Jaime Koralewski

Jaime Koralewski has a diverse work experience spanning over two decades. Currently, Jaime holds the position of Associate Director, Quality Compliance at Sage Therapeutics, starting in November 2022. In this role, Jaime partners with various functional areas to achieve quality objectives and serves as an expert in good clinical practices (GCP) and good laboratory practices (GLP). Jaime also stays updated on regulatory requirements and industry compliance strategies.

Prior to joining Sage Therapeutics, Jaime worked at Sanofi Pasteur for numerous years. From December 2019 to November 2022, Jaime served as Associate Director, Operational Compliance, supporting global immunology and operations functions. Responsibilities included overseeing quality oversight for GCP and GCLP in clinical trial sample testing, leading regulatory and self-inspection programs, and managing deviations, CAPAs, and validation.

Before that, from April 2017 to December 2019, Jaime held the role of Deputy Director, Good Clinical Laboratory Practices (GCLP) Management. Responsibilities included leading a compliance team overseeing GCP and GCLP quality in North America, contributing to the implementation of a risk-based quality oversight model, and supporting deviations, CAPAs, and validation.

From December 2013 to April 2017, Jaime served as Manager, R&D Site Quality Operations, with responsibilities including quality assurance oversight of GCLP testing and leading internal and vendor inspections.

Jaime's early career included roles at Medarex and PPD. At Medarex (2005-2007), Jaime was an Associate Scientist involved in developing and validating assays and overseeing testing for pre-clinical toxicology studies and human clinical studies. At PPD (2005), Jaime worked as an Associate Scientist in quality control, conducting cell-based ELISAs and following client SOPs and GMPs.

Before entering the pharmaceutical industry, Jaime worked as an Analytical Chemist at Praxair Distribution, Inc. (2004-2005), performing testing and releasing gas mixtures in accordance with regulatory requirements.

Overall, Jaime Koralewski's work experience demonstrates strong expertise in quality compliance, GCP/GLP, regulatory oversight, and managing deviations and CAPAs in the pharmaceutical industry.

Jaime Koralewski completed a Bachelor of Science (B.S.) degree in Molecular Biology at Lehigh University from 1999 to 2003. Additionally, Jaime obtained certifications as a Certified Quality Auditor (CQA) and a Certified Manager of Quality and Organizational Excellence (CMQ/OE) from the ASQ - World Headquarters in December 2015 and May 2015, respectively.