Mackenzie Grady

Quality professional with 18 years’ experience in GMP/GCP/GLP/GXP regulated environments supporting development, clinical and commercialization of pharmaceutical, biotech, oglio and gene/cell therapy products. I have worked in Supplier Quality/Auditing, Global Product Quality, Quality Assurance (QA) and Quality Control (QC) roles that require analytical thinking, attention to detail, critical problem-solving skills, project management, and diligent work ethic. I have continuously assumed increased levels of responsibility by demonstrating ability to manage multiple tasks, prioritization, demanding timelines, supervision/management of individuals and alignment with all departments for compliance and successfully meeting performance objectives. Extensive experience with 21CFR, ISO13485/9001 and ICH Q1-Q12 regulations and pharmacopeia (USP, EP). Strong communication, leadership and interpersonal skills, familiar working in multidisciplinary team structures. A quick learner with strong computer skills including all MS Office and applications/systems widely used in the pharmaceutics industry (e.g. Trackwise, Infinity/Veeva, LIMS, SAP, DCA, Master Control, Success Factors etc.) Motivated for continual growth, leadership and provide mentoring in a fast-paced and energetic environment.

ASQ Lead Auditor Certification

Six Sigma Yellow Belt Certification

iPEC Life Coach Certification