Commercial Quality Control Leader, Release & Compliance

amylyx; Cambridge (MA); Remote; USD 180,000 - 240,000; Full time

Job summary

Amylyx is seeking an Associate Director of Quality Control to lead commercial QC operations across external CMOs and CTLs, ensuring inspection readiness and global compliance for marketed products.

You will build and guide the QC team, manage stability programs, specifications, method transfers, and regulatory filings while collaborating with Manufacturing, Regulatory, Analytics, and Quality Assurance.

Qualifications

• 8+ years in quality control with 6+ years in industry.
• Experience supporting commercial GMP products.
• Knowledge of USP, EP, JP, cGMP, ICH and data integrity.

Responsibilities

• Lead and manage Amylyx' commercial QC function across external CMOs and CTLs.
• Monitor quality and operational performance of external testing partners.
• Oversee commercial stability programs and data review.

Skills

Quality control leadership

Regulatory compliance

Cross-functional collaboration

Communication skills

Education

Bachelor's or MS in chemistry/biochemistry

Tools

Analytical method validation tools

Job description

Amylyx is seeking an Associate Director of Quality Control to lead commercial QC operations across external CMOs and CTLs, ensuring inspection readiness and global compliance for marketed products.

You will build and guide the QC team, manage stability programs, specifications, method transfers, and regulatory filings while collaborating with Manufacturing, Regulatory, Analytics, and Quality Assurance.