Associate Director, Global Commercial Quality Control

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 171,000 - 192,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. is seeking an Associate Director of Quality Control to lead commercial QC operations within a fully outsourced network.

The role emphasizes inspection readiness, global compliance, and collaboration across Manufacturing, Regulatory Affairs, and QA to ensure timely commercial lot release and market supply. The position requires extensive QC leadership experience, strong knowledge of GMP and regulatory expectations, and the ability to build and scale a high-performing

Qualifications

• 8+ years of experience with at least 6+ years in industry Quality Control.
• Experience supporting commercial GMP products.
• Knowledge of USP/EP/JP, cGMP, ICH, data integrity, and global release expectations.
• Experience with method transfer, validation maintenance, and troubleshooting across contract labs.
• Experience managing and developing people; strong communication skills.

Responsibilities

• Lead commercial QC function across external CMOs and CTLs for materials and product testing.
• Monitor external partners via governance, metrics, deviations, CAPA oversight.
• Oversee commercial stability programs, trend reviews, shelf-life commitments, and post-approval stability.
• Manage specification lifecycle, including post-approval revisions and market-specific requirements.
• Ensure lifecycle management of analytical methods across outsourced labs.
• Author and approve QC documents, specs, and validation reports.
• Collaborate with Manufacturing, Regulatory, Analytical Development, and QA for lot release and supply.
• Manage one direct report initially, with plans to grow the QC team.

Skills

Quality control leadership

Cross-functional collaboration

Regulatory compliance knowledge

Data integrity awareness

Analytical thinking

Education

Bachelor's or MS in chemistry/biochemistry

Tools

GMP systems

LIMS

Job description

Amylyx Pharmaceuticals, Inc. is seeking an Associate Director of Quality Control to lead commercial QC operations within a fully outsourced network.

The role emphasizes inspection readiness, global compliance, and collaboration across Manufacturing, Regulatory Affairs, and QA to ensure timely commercial lot release and market supply. The position requires extensive QC leadership experience, strong knowledge of GMP and regulatory expectations, and the ability to build and scale a high-performing