Manager, Quality Operations

Amylyx Pharmaceuticals • Cambridge, MA

1d • Remote

About The Position

This position provides CMC quality oversight of drug substance manufacturing, packaging, and distribution. As the CMC quality expert, the Manager is accountable for ensuring company, regional, and global GMP and GDP standards and regulations are met, and that the CMC Quality department ensures the quality of products and materials produced by Amylyx’s contracted partners.

The role provides quality oversight across drug substance production, quality-system records, batch documentation, manufacturing and distribution procedures, and regulatory submissions. It also serves as a Quality subject matter expert in internal and external meetings and supports regulatory agency inspections. The position is remote within the United States, subject to state eligibility restrictions, with travel to Cambridge, Massachusetts several times a year and other travel as needed. Travel may be required up to 10% within the United States, including on-site review of third-party operations.

Requirements

• At least 5 years of experience with a bachelor’s degree in Pharmaceutical Sciences, or at least 3 years of experience with an advanced degree in Pharmaceutical Sciences.
• At least 3 years of directly related experience with peptide and/or oligonucleotide (ASO) manufacturing, including quality operations, QC, or MSAT.
• Experience authoring and reviewing NDA CMC sections and addressing regulatory filing requirements in FDA cGMP regulations, EudraLex, ICH guidance, and other biopharma industry guidance and regulations.
• Ability to work with all organizational levels and external contract service providers to ensure compliance with current regulations.
• Access to a remote work setting that supports role requirements, including privacy, reliable internet, phone, and video conferencing.
• Availability for travel, which may be required up to 10% within the United States.

Nice To Haves

• QC experience.

Responsibilities

• Provide quality oversight of drug substance production activities.
• Provide QA review and approval of drug substance and equipment validation documents, master production records, product specifications, analytical method qualification and validation documents, method transfer documents, and stability plans.
• Review executed Batch Production and QC Control Records to ensure approved procedures were followed and specifications were met.
• Prepare and/or approve batch disposition packages.
• Provide QA review and approval of quality-system records, including deviations, OOS records, change controls, CAPAs, and product quality complaints.
• Lead or participate in internal and external meetings as a Quality SME to ensure quality expectations are met for GMP, GDP, and Good Documentation Practice.
• Write, review, and/or approve SOPs as a QA SME for manufacturing, labeling, packaging, and transportation of late-stage and commercial products.
• Provide QA review of NDAs.
• Ensure source data and information used in regulatory submissions and validation activities are maintained and traceable.
• Support FDA, EMA, and other regulatory agency inspections.

Benefits

• Eligible employees may receive annual performance-based bonuses.
• Eligible employees may receive equity awards.
• Comprehensive benefits package designed to support employees’ health, well-being, and financial security.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager