Lead – QMS & Training

THE OPPORTUNITY

The Lead, Quality Management Systems (QMS) & Training position is primarily responsible for developing, maintaining, and executing all training aspects within Quality Management Systems and processes to ensure GxP compliance. This position 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, including process improvement implementations that meet business and regulatory requirements. This position is part of the Quality Management Systems team that includes responsibilities for Product Quality Complaints, APQR, Recalls, Inspection Readiness and supporting Computer System Validation.

This role partners with internal departments and external service providers (as needed) to evolve training systems and programs that ensure personnel qualifications at Amylyx.  With expansion of the company, this role will support the implementation and operation of both clinical and future commercial quality systems. 

THE RESPONSIBILITIES

• Responsible for overseeing activities related to Training and Personnel Qualification, including creation and maintaining curricula and associated documentation, to ensure individuals meet GxP compliance and regulatory requirements.
• Own implementation, validation, and management for training systems, including software validation and User Acceptance Testing (UAT), through working closely with IT.
• Monitor the overall health of Training compliance, generate meaningful KPIs and drive continuous improvement of the training system.
• Coordinate workflows for GxP documentation and training updates; at times will/may include Deviations, OOS, investigations, etc. that occur during production and testing, supporting proper creation of CAPA and other applicable remediation plans.
• Partner with departments to facilitate their writing, review and/or approval of their SOPs for clinical and commercial systems to ensure they are integrated into the training system/process.
• Provide system oversight, ensure system compliance and usage to regulatory and corporate requirements as they relate to training, document control and lifecycle records management.
• Support implementation and qualification of software for all Quality Management Systems as needed.
• Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives.
• Participate in inspection readiness across the GxP departments

REQUIRED QUALIFICATIONS

• B.S. in Pharmaceutical Sciences, Biotechnology or equivalent (advanced degree a plus).
• Minimum 5 years of experience within the Pharmaceutical or Biotechnology industry in a quality role.
• Working knowledge of QMS electronic platforms e.g. Veeva, Pilgrim, TrackWise, ZenQMS, etc. (Experience with Veeva a plus)
• Ability to partner with all levels of the organization and external contract service providers to ensure compliance with current regulations.
• Experience in developing and implementing GxP quality and Training systems to meet regulatory and industry standards.
• Knowledgeable in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
• Experience in supporting functions during FDA, EMA or other regulatory agency inspections.
• Travel may be required up to 10%, which may include on-site review of third-party operations

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.