Associate Director, Quality Operations
About the Role
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. This position is responsible for providing CMC quality oversight of drug substance, drug product, and finished drug product manufacturing, testing, packaging, labeling, and distribution for non-commercial products that are in various development stages. As the GMP quality expert, this role ensures all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality department performs to a standard that ensures the quality of products and materials produced by Amylyx contracted partners.
We anticipate hiring the Associate Director, Quality Operations in September 2026.
Responsibilities
- Provide quality oversight of production, labeling, and testing activities, including warehousing and distribution of clinical trial materials.
- Provide QA review and approval on quality technical agreements, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans.
- Review executed Batch Production and QC Control Records to ensure all approved procedures were followed and all specifications are met.
- Prepare and/or approve batch disposition packages.
- Provide QA review and approval on quality system records, including but not limited to deviations, OOS, change controls, CAPAs, and product quality complaints.
- Lead or participate in regular meetings internally and externally as CMC Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
- Provide QA review on INDs. Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
- Write, review, and/or approve SOPs as QA SME for manufacturing, testing, labeling, packaging, and transportation of early-stage products.
- Support FDA, EMA, or other regulatory agency inspections.
Requirements
- Bachelor’s degree.
- 8+ years of experience within the Pharmaceutical or Biotechnology industry in a quality role.
- Experience with authoring and reviewing IND CMC sections and addressing Regulatory Filing requirements in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations.
- Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations.
- Travel may be required up to 10%, which may include on-site review of third-party operations.
Preferred Qualifications
- QC/AD experience.
- Small molecule and peptides experience.
Work Location and Conditions
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations, we are unable to hire employees who reside and/or work in Alaska, Arizona, Hawaii, Michigan, and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary.
- You must have access to a work setting that enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
Pay
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
Estimated Pay Range: $172,000 - $194,000 USD