Mary MacDonald, MS, RQAP-GCP
Head of Clinical Quality Assurance, Neuroscience
Takeda Pharmaceuticals
Mary MacDonald is the Head of Clinical Quality Assurance, Neuroscience with Takeda and is a key member of the Clinical Quality Assurance leadership team.
In this role, Mary partners with the Neuroscience Therapeutic Area Unit and additional quality and research and development business partners to ensure compliance and inspection readiness for all Takeda clinical development programs and studies.
Mary has over 25 years of experience in clinical quality assurance and compliance, operational excellence, GxP auditing and clinical trial site research management.
Mary was previously with Alexion, AstraZeneca Rare Disease where she served as the Director of Clinical Development and Operations Quality Center of Excellence and had responsibility for leading Clinical Development process improvement, knowledge management, SOP integration, learning and development and controlled document management. She also served as a Clinical Quality Operations Lead for the acquisition of Portola Pharmaceuticals andexanet program and for the Alexion Phase I program.
Prior to this, Mary served as the Director of Clinical Quality Assurance for the Oncology franchise at Radius Health, supporting the elacestrant studies leading to the first FDA approval for an oral SERD for metastatic breast cancer. Previous roles also include working as a Senior Auditor and leading the bluebird bio GCP/GVP/GCLP audit program supporting the first approved gene therapies for beta thalassemia, cerebral adrenoleukodystrophy and cell therapy for multiple myeloma, as well as the ongoing gene therapy trials for sickle cell anemia. Prior to her experience in the pharmaceutical industry, Mary spent many years working as a research coordinator at Brigham & Women’s Hospital Sleep Disorders Program and the Center for Resuscitation Science at Beth Israel Deaconess Medical Center in Boston.
Mary holds a Master of Science degree in Clinical Research Organization and Management from Drexel University and a Bachelor of Arts degree in History from Smith College.
Mary is passionate about developing innovative and risk-based quality and compliance strategies that accelerate the delivery of life-saving therapies to patients, and leading teams motivated by their commitment to patient-centricity, collaboration, creativity, compassion and doing the right thing.