Associate Director, Quality Operations
Amylyx Pharmaceuticals
August 07, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Provide CMC quality oversight of drug substance, drug product, and finished drug product manufacturing/testing/packaging/labeling/distribution for non-commercial products in development.
- Ensure GMP/GDP compliance and quality standards are met by contracted partners.
- Oversee production, labeling, testing, warehousing, and distribution of clinical trial materials.
- Perform QA review/approval of quality technical agreements, master production records, product specifications (in-process/release/stability), analytical method qualification/validation, method transfer, and stability plans.
- Review executed Batch Production and QC Control Records; ensure approved procedures and specifications are met.
- Prepare/approve batch disposition packages.
- QA review/approval of quality system records: deviations, OOS, change controls, CAPAs, and product quality complaints.
- Serve as CMC Quality SME in internal/external meetings (GMP/GDP/documentation).
- Provide QA review on INDs; ensure regulatory submission/validation source data is maintained and traceable.
- Write/review/approve SOPs for manufacturing, testing, labeling, packaging, and transportation of early-stage products.
- Support FDA/EMA/other regulatory inspections.
Required Qualifications:
- Bachelor’s degree.
- 8+ years in pharmaceutical/biotech quality.
- Experience authoring/reviewing IND CMC sections and meeting FDA cGMP, Eudralex, ICH, and related biopharma guidance.
- Ability to work across organizations and with external contract service providers.
- Travel up to 10%.
Preferred Requirements:
- QC/AD experience.
- Small molecule and peptides experience.
Compensation:
- Estimated pay range: $172,000–$194,000 USD.
Work Location/Conditions:
- Remote in the U.S. (not considering AK, AZ, HI, MI, TN); travel to Cambridge, MA several times/year and have reliable remote work setup.
- Provide CMC quality oversight of drug substance, drug product, and finished drug product manufacturing/testing/packaging/labeling/distribution for non-commercial products in development.
- Ensure GMP/GDP compliance and quality standards are met by contracted partners.
- Oversee production, labeling, testing, warehousing, and distribution of clinical trial materials.
- Perform QA review/approval of quality technical agreements, master production records, product specifications (in-process/release/stability), analytical method qualification/validation, method transfer, and stability plans.
- Review executed Batch Production and QC Control Records; ensure approved procedures and specifications are met.
- Prepare/approve batch disposition packages.
- QA review/approval of quality system records: deviations, OOS, change controls, CAPAs, and product quality complaints.
- Serve as CMC Quality SME in internal/external meetings (GMP/GDP/documentation).
- Provide QA review on INDs; ensure regulatory submission/validation source data is maintained and traceable.
- Write/review/approve SOPs for manufacturing, testing, labeling, packaging, and transportation of early-stage products.
- Support FDA/EMA/other regulatory inspections.
Required Qualifications:
- Bachelor’s degree.
- 8+ years in pharmaceutical/biotech quality.
- Experience authoring/reviewing IND CMC sections and meeting FDA cGMP, Eudralex, ICH, and related biopharma guidance.
- Ability to work across organizations and with external contract service providers.
- Travel up to 10%.
Preferred Requirements:
- QC/AD experience.
- Small molecule and peptides experience.
Compensation:
- Estimated pay range: $172,000–$194,000 USD.
Work Location/Conditions:
- Remote in the U.S. (not considering AK, AZ, HI, MI, TN); travel to Cambridge, MA several times/year and have reliable remote work setup.