Vadim I.
About Vadim I.
Vadim I. serves as the Lead for Computer Systems Quality at Amylyx Pharmaceuticals, specializing in GxP Computerized Systems Quality and Global Compliance. He has extensive experience in quality assurance across various roles in the biotechnology and life sciences sectors.
Current Role at Amylyx Pharmaceuticals
Vadim I. serves as the Lead for Computer Systems Quality at Amylyx Pharmaceuticals, a position he has held since 2023. In this role, he focuses on ensuring the quality and compliance of computerized systems within the organization. His responsibilities include overseeing data integrity processes and implementing quality assurance measures that align with industry standards.
Previous Experience at Sage Therapeutics
Vadim I. worked at Sage Therapeutics as the Senior Manager of Quality Assurance for Computerized Systems from 2019 to 2023. During his tenure in Cambridge, Massachusetts, he specialized in GxP Computerized Systems Quality and Global Compliance, emphasizing design assurance and validation. His role contributed to the overall quality management within the organization.
Background in Quality Assurance and Validation
Vadim I. has extensive experience in quality assurance and validation, having worked in various capacities from 2001 to 2009 in the Greater Chicago Area. His roles included Software Quality Assurance (SQA), IT Project Management (PM), and Business Analysis (BA). This foundational experience has informed his subsequent positions in the biotechnology and life sciences sectors.
Expertise in GxP Computerized Systems
Vadim I. specializes in GxP Computerized Systems Quality and Global Compliance. He has a strong focus on design assurance and validation, which are critical components in maintaining compliance within regulated industries. His expertise extends to Computer Software Assurance (CSA) and Quality Management Systems (QMS), contributing significantly to quality management practices in biotechnology.
Career Progression and Roles
Vadim I. has held various positions throughout his career, including Software Quality Assurance Manager at Roche from 2012 to 2016 and Quality Assurance Lead at Vitech Systems Group from 2009 to 2012. He also worked as a Senior Quality Consultant in the BioPharma and Medical Devices sectors from 2016 to 2019. His diverse roles reflect a commitment to quality assurance and compliance in complex environments.