This position is responsible for providing CMC quality oversight of drug substance manufacturing, packaging and distribution.

As the CMC quality expert, this role is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the CMC Quality department performs to a standard that ensures the quality of products and materials produced by Amylyx contracted partners.

Provide quality oversight of drug substance production activities.

Provide QA review and approval on drug substance 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.

Manager, Quality Operations

Responsibilities

Qualification

Required

Preferred

Benefits

Company

Amylyx

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