Lead, GMP Quality

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.

At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• AMX0035 is currently under review with the European Medicines Agency
• 350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

THE ROLE

The Lead of GMP Quality is responsible for providing operational quality oversight of bulk drug product and finished drug product manufacturing, testing, packaging, labeling and distribution. This role provides support on Quality Management Systems within GMP operations for internal implementation as well as integration with contracted partners. As the GMP quality expert, this role is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality department performs to a standard that ensures the quality of products and materials produced by Amylyx contracted partners.  As we prepare for global commercialization, this role will support the implementation and operation of commercial quality systems.

RESPONSIBILITIES

• Provide quality oversight of production and testing activities, including warehousing and distribution of clinical and commercial products. Participate in regular meetings with CMOs, CTLs and 3PLs.
• Directly manage the batch release/disposition team. 
• Review and evaluate Batch Production and QC Control Records for Bulk Drug Product and Finished Drug Product to ensure all approved procedures were followed and all specifications are met. 
• Prepare and /or approve product disposition for bulk drug product, IP/IMP and FDP.
• Provide QA support for non-compliance events for example, deviations, OOS, investigations, etc. that occur during production and testing, investigate and support remediation.
• Provide QA review and approval for Quality Systems for example change controls, CAPA, quality product complaints, etc. 
• Provide quality oversite and support of labeling documentation. Ensure proper version control and document integrity of packaging component labeling, specifications, printed labeling artworks, etc.
• Ensure Amylyx’s quality expectations are being met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice. 
• Provide QA oversite of documents associated with testing, stability, method qualification / validation, method transfer, etc. 
• Write, review and/or approve SOPs for QA clinical and commercial systems e.g. software usage, complaints, annual product review. 
• Support implementation and qualification of software for Quality Management Systems 
• Review and approve SOPs related to QC and supply chain clinical and commercial operations e.g. artwork management, method validation/qualification/transfer, specification management, etc. 
• Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
• Support quality improvements to maintain compliance and improve efficiency as part of continuous improvement initiatives. 
• Manage Annual Product Quality Reviews. 
• Participate in regular meetings held by the Quality organization and represent Amylyx Quality at cross-functional meetings and improvement initiatives.

REQUIREMENTS

• B.S. in Pharmaceutical Sciences or related scientific discipline. 
• Minimum 8 years of experience within the Pharmaceutical or Biotechnology industry in a quality role. 
• Experience with CMC and Regulatory Filing requirements.
• Ability to provide team leadership in the areas of: batch review and release, product disposition, change control and deviations within quality events. 
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regula