Dr. Kieran Fitzgerald C Chem
About Dr. Kieran Fitzgerald C Chem
Dr. Kieran Fitzgerald is the Head of Quality EMEA at Amylyx Pharmaceuticals, with extensive experience in quality operations across various pharmaceutical companies. He has held significant roles at Horizon, HUYA Bioscience International, and Jazz Pharmaceuticals, and possesses a strong academic background in chemistry and management.
Current Role at Amylyx Pharmaceuticals
Dr. Kieran Fitzgerald serves as the Head Quality EMEA at Amylyx Pharmaceuticals, a position he has held since 2022. Based in Dublin, County Dublin, Ireland, he oversees quality assurance processes and compliance across the EMEA region. His role involves ensuring that the company's products meet regulatory standards and maintaining high-quality operational practices.
Previous Experience in Quality Operations
Prior to his current role, Dr. Fitzgerald held several significant positions in quality operations. He worked as Executive Director of Quality Operations and CMC at Horizon from 2015 to 2019. Before that, he served as QA Projects Manager at Shire from 2010 to 2013 and as Director of Quality Assurance at Jazz Pharmaceuticals from 2013 to 2015. His extensive background in quality management spans various organizations, contributing to his expertise in the field.
Educational Background and Qualifications
Dr. Fitzgerald has a strong educational foundation in science and management. He earned a Bachelor of Science degree from University College Cork, followed by a PhD in Synthetic Organic Chemistry from the same institution. Additionally, he completed a Project Management Professional (PMP) certification at PMI in 2010 and obtained diplomas in Organizational Leadership and Strategy and Innovation from the Irish Management Institute in 2016 and 2017, respectively.
Expertise in Quality Management Systems
Dr. Fitzgerald possesses extensive knowledge in Electronic Systems (QMS) and Computer System Validation (CSV). He specializes in Quality by Design Innovation and has experience in setting up Global Quality Management Systems. His expertise also includes compliance with FDA, MHRA, GDPR, and HIPAA regulations, as well as familiarity with 21 CFR part 11 regulations concerning Electronic Signatures.
Specialization in Regulatory Compliance
Dr. Fitzgerald has significant experience in managing Supply Chain Models with EU/EEA GDP implications. He is knowledgeable in Clinical Quality Oversight in accordance with ICH E6 guidelines and has been involved in the setup of EU Marketing Authorization and Japan MAH/Product Launch. His focus on BREXIT Remediation and Contingency further demonstrates his commitment to navigating regulatory challenges in the pharmaceutical industry.