Remote Lead, Quality Management System & Training

Summary

Join Amylyx as a Lead, Quality Management Systems (QMS) & Training to develop and maintain training aspects within Quality Management Systems and processes to ensure GxP compliance. This role will have primary responsibility for training aspects within the GXP systems, including supporting the Documentation Management System (DMS), Learning Management System (LMS) and Quality Management System (QMS) for Deviations, CAPAs, change control and complaints.

Requirements

• B.S. in Pharmaceutical Sciences, Biotechnology or equivalent (advanced degree a plus)
• Minimum 5 years of experience within the Pharmaceutical or Biotechnology industry
• Working knowledge of QMS electronic platforms e.g. Veeva, Pilgrim, TrackWise, ZenQMS, etc
• Ability to partner with all levels of the organization and external contract service providers
• Experience in developing and implementing GxP quality and Training systems
• Knowledgeable in FDA cGMP regulations, Eudralex and ICH Guidance

Responsibilities

• Responsible for overseeing activities related to Training and Personnel Qualification
• Own implementation, validation, and management for training systems
• Monitor the overall health of Training compliance
• Coordinate workflows for GxP documentation and training updates
• Partner with departments to facilitate their writing, review and/or approval of their SOPs
• Provide system oversight, ensure system compliance and usage
• Support implementation and qualification of software for all Quality Management Systems
• Support quality improvements to maintain compliance and improve efficiency

Benefits

Remote friendly role