Associate Director, Quality Operations

Amylyx Pharmaceuticals•Cambridge, MA

3d•Remote

About The Position

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 is accountable for ensuring 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.

Requirements

Bachelors 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.

Nice To Haves

QC/AD experience is preferred.

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.