Senior Director, Quality Operations & CMC (GMP)

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 172,000 - 194,000; Full time

Job summary

Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products in development stages. The role ensures compliance with GMP/GDP standards and supervises activities with contract partners.

The position focuses on QA oversight of manufacturing, testing, labeling, packaging, and distribution for clinical materials, with responsibilities spanning IND reviews, SOP authoring, and regulatory inspections.

Qualifications

• Bachelor's degree in a relevant field.
• 8+ years of experience in pharmaceutical/biotech quality roles.
• Experience authoring and reviewing IND CMC sections and regulatory filing knowledge.
• Ability to work with all levels of the organization and external contract service providers.
• Travel up to 10% may be required.

Responsibilities

• Provide quality oversight of production, labeling and testing activities including warehousing and distribution of clinical materials.
• Provide QA reviews on quality system records (deviations, OOS, CAPAs, complaints).
• Write/review/approve SOPs as QA SME for manufacturing, testing, labeling and transportation.
• Support FDA/EMA inspections and regulatory interactions.

Skills

Quality oversight

Regulatory submissions

IND CMC experience

Contractor coordination

Education

Bachelor's degree

Job description

Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products in development stages. The role ensures compliance with GMP/GDP standards and supervises activities with contract partners.

The position focuses on QA oversight of manufacturing, testing, labeling, packaging, and distribution for clinical materials, with responsibilities spanning IND reviews, SOP authoring, and regulatory inspections.