Colleen Grace

Colleen Grace has over 25 years of experience in the pharmaceutical industry. Colleen is currently working as the Associate Director of QA Compliance at XGen Pharmaceuticals DJB. Prior to this, they worked at Pharmalucence as the Analytical Development Compliance Manager from 2015 to 2020. In this role, they managed the creation and implementation of quality systems, coordinated global analytical method validation and transfer processes, and led cross-functional teams for compliance and efficiency programs.

Before Pharmalucence, Colleen worked as a Project Lead and Principal Scientist at Bayer from 2014 to 2015. At Bayer, they supervised method validation and stability processes and managed cross-functional teams for product launches. From 2003 to 2014, they held the position of Team Leader for R&D Quality and Compliance at Merck Consumer Care, where they implemented quality system improvements and managed the implementation of quality procedures and standards.

Colleen also has experience at Schering-Plough Research Institute as the Self-Inspection Program Leader, where they managed the Analytical Development Self-Inspection Program and facilitated audits and inspections. At Pharmacia, they worked as the Manager of Corporate QA, providing support and guidance to multiple departments and conducting compliance assessments.

Their career began at Amgen as a Research Scientist III, where they supervised analysts and performed method transfers and validations. Colleen also worked as a Pharmaceutical Analysis Chemist at Penwest Pharmaceuticals, optimizing and validating analytical methodology and implementing a stability program. Colleen started their career at Schein Pharmaceuticals as a Chemist, responsible for routine testing and training new laboratory personnel.

Throughout their career, Colleen has demonstrated expertise in quality systems, compliance, method validation, stability programs, and cross-functional team management.

Colleen Grace completed their Bachelor of Science degree in Biology from the University of Michigan from 1989 to 2003. Colleen then pursued a Master of Science degree in Quality Assurance & Regulatory Affairs from Temple University from 2004 to 2007. Prior to their undergraduate studies, they attended BA High School from 1986 to 1989.