Remote-Eligible CMC Quality Operations Manager

Amylyx Pharmaceuticals; United States; Remote; USD 129,000 - 145,000; Full time

Benefits offered by this job

Remote work within the United States

Annual performance bonuses

Equity awards

Comprehensive benefits

Job summary

Amylyx Pharmaceuticals seeks a CMC Quality expert to oversee drug substance manufacturing, packaging and distribution under GMP/GDP standards.

You will ensure regulatory compliance, review validation and batch records, and support FDA/EMA inspections while coordinating with contract partners and internal teams. The role emphasizes QA leadership, SOP management, and regulatory documentation expertise.

Qualifications

• Minimum 5 years of experience with a B.S. in Pharmaceutical Sciences.
• Minimum 3 years of experience with advanced degrees in Pharmaceutical Sciences.
• Experience with NDA CMC sections and FDA cGMP/Eudralex guidance.
• Ability to coordinate with internal teams and external providers.

Responsibilities

• Provide quality oversight of drug substance production activities.
• QA review and approval of validation documents, MPRs, specs, and stability plans.
• Review batch records to ensure procedures and specifications are met.
• Lead QA review of deviations, OOS, CAPAs, and PQs; support inspections.
• Draft, review and approve SOPs for manufacturing, labeling, packaging, and transport.

Skills

Quality oversight

Regulatory liaison

Communication with external providers

Attention to detail

Education

B.S. in Pharmaceutical Sciences

Advanced degree in Pharmaceutical Sciences

Job description

Amylyx Pharmaceuticals seeks a CMC Quality expert to oversee drug substance manufacturing, packaging and distribution under GMP/GDP standards.

You will ensure regulatory compliance, review validation and batch records, and support FDA/EMA inspections while coordinating with contract partners and internal teams. The role emphasizes QA leadership, SOP management, and regulatory documentation expertise.