Manager, Quality Operations

Amylyx Pharmaceuticals•Cambridge, MA

4d•Remote

About The Position

This position is responsible for providing CMC quality oversight of sterile drug product and finished drug product manufacturing, labeling, packaging and distribution operations. 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

Bachelor's degree with 5+ years of experience in Quality Operations, Quality Control (QC), Manufacturing Science & Technology (MSAT), or related pharmaceutical manufacturing functions; or Advanced degree (Master's, PhD, or equivalent) with 3+ years of experience in Quality Operations, Quality Control (QC), Manufacturing Science & Technology (MSAT), or related pharmaceutical manufacturing functions.
Must have at least 3 years of hands-on experience supporting sterile or aseptic manufacturing environments, including but not limited to quality operations, QC, MSAT, etc.
Experience with authoring and reviewing NDA 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

Experience with environmental monitoring is highly preferred.
Direct experience with serialization is highly preferred.

Responsibilities

Provide quality oversight of Drug Product and Finished Drug Product production activities.
Provide QA review and approval on sterile drug product process validation documents, equipment validation documents, 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 Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice.
Write, review and/or approve SOPs as QA SME for manufacturing, labeling, packaging, and transportation of late stage and commercial products.
Provide QA review on NDAs.
Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable.
Support FDA, EMA or other regulatory agency inspections.