Head, Quality Management Systems

Summary

Join Amylyx Pharmaceuticals as their Head of Quality Management Systems! This role oversees the development, maintenance, and execution of Quality Management Systems (QMS) to ensure GxP compliance. You will manage a team, implement and validate systems for deviations, CAPAs, complaints, and change control, and ensure data integrity and computer system validation. The position requires a strong background in pharmaceutical quality systems and regulatory compliance. This remote-friendly role offers the opportunity to contribute to a growing company dedicated to improving the lives of people with neurodegenerative diseases. The ideal candidate will have extensive experience in the pharmaceutical industry and a proven track record of managing quality systems and teams. This role requires strong leadership, collaboration, and problem-solving skills.

Requirements

• B.S. in Pharmaceutical Sciences (advanced degree a plus)
• Minimum 10-12 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
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations
• Experience in developing and implementing GxP quality 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

Responsibilities

• Manage implementation, validation, and management for deviations, CAPA, Complaints and Change Control
• Monitor the overall health of the QMS, generate KPIs and drive continuous improvement of the QMS
• Responsible for Quality oversight of Data Integrity and Computer System Validation activities
• Approve and review non-compliance events, for example, deviations, OOS, investigations, etc. that occur during production and testing, investigate and support remediation
• Oversee operations of the Document Control and Records Management and the Training and Personnel Qualification processes
• Develop training strategies and materials that support GXP activities, including continuous improvement initiatives
• Write, review and/or approve SOPs for QA clinical and commercial systems e.g. software usage, complaints, annual product review
• Provide system oversight and ensure system compliance and usage to regulatory and corporate requirements as they related to document control and records management
• Manage Annual Product Quality Reviews
• Support cross functional teams in processing document requests, document approval, and document archival
• Support implementation and qualification of software for Quality Management Systems
• Review and approve SOPs for quality
• Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives
• Represents Amylyx QA. Creates Agendas and manage resources to drive Amylyx needs and timelines
• Promote a Culture of Quality through collaboration

Preferred Qualifications

Experience managing people and/or multi-functional projects preferred

Benefits

• 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