Manager, Quality Operations

About the role

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. This position is responsible for providing CMC quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging, and distribution operations. As the GMP quality expert, this role ensures all company, regional, and global GMP and GDP standards and regulations are met, maintaining the quality of products and materials produced by Amylyx contracted partners. We anticipate hiring the Manager, Quality Operations in September 2026.

Responsibilities

• Provide quality oversight of Drug Product and Finished Drug Product production activities.
• Provide QA review and approval on sterile drug product process validation documents, equipment validation documents, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans.
• Review executed Batch Production and QC Control Records to ensure all approved procedures were followed and all specifications are met.
• Prepare and/or approve batch disposition packages.
• Provide QA review and approval on quality system records, including but not limited to deviations, OOS, change controls, CAPAs, and product quality complaints.
• Lead or participate in regular meetings internally and externally as Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
• Write, review, and/or approve SOPs as QA SME for manufacturing, labeling, packaging, and transportation of late-stage and commercial products.
• Provide QA review on NDAs. Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
• Support FDA, EMA, or other regulatory agency inspections.

Requirements

• Bachelor's degree with 5+ years of experience in Quality Operations, Quality Control (QC), Manufacturing Science & Technology (MSAT), or related pharmaceutical manufacturing functions; or Advanced degree (Master's, PhD, or equivalent) with 3+ years of experience in the same fields.
• At least 3 years of hands-on experience supporting sterile or aseptic manufacturing environments, including but not limited to quality operations, QC, MSAT, etc.
• Experience with authoring and reviewing NDA CMC sections and addressing Regulatory Filing requirements in FDA cGMP regulations, Eudralex, and ICH Guidance, as well as other Biopharma industry guidance and regulations.
• Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
• Travel may be required up to 10% within the US, which may include on-site review of third-party operations.

Preferred Qualifications

• Experience with environmental monitoring is highly preferred.
• Direct experience with serialization is highly preferred.

Work Location and Conditions

• Remote work opportunities within the United States, excluding Alaska, Arizona, Hawaii, Michigan, and Tennessee.
• Expected to travel to the corporate location in Cambridge, MA several times a year and attend other company-related events as necessary.
• Must have access to a work setting that enables meeting all requirements of the role, including privacy, reliable internet access, phone, and ability to video conference at your remote location.

Pay

Estimated Pay Range: $129,000 - $145,000 USD. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.