Head – Quality Management Systems

THE OPPORTUNITY

Amylyx is looking for a Head of Quality Management Systems who oversees the Quality Systems that are responsible for developing, maintaining, and executing Quality Management Systems (QMS) and processes to ensure GxP compliance. Oversees the GXP systems by developing and 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. The Quality Management Systems team is responsible for complaints, APQR, Recalls and Quality oversight of Computer System Validation.

This role oversees Quality Management Systems and manages their team for internal implementation as well as integration with contracted partners.  With the expansion of the company, this role will support the implementation and operation of development and commercial quality systems.

THE RESPONSIBILITIES

• Manages a team and directly performs the following:
• 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

REQUIRED QUALIFICATIONS

• 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.
• Experience managing people and/or multi-functional projects preferred.
• 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.