Manager, Quality Operations

Socket.dev; Cambridge (MA); On-site; USD 129,000 - 145,000; Full time

Job summary

Amylyx Pharmaceuticals seeks a Manager, Quality Operations to provide QA oversight of sterile drug product manufacturing, labeling, packaging and distribution. You will ensure GMP/GDP standards are met and that the QA function supports contracted partners to deliver safe, compliant products.

You will collaborate across functions, author/review QA documentation, and prepare for regulatory inspections, with travel to Cambridge, MA and remote work options within the United States.

Qualifications

• Bachelor's degree with 5+ years in Quality Operations, QC, MSAT, or related pharmaceutical manufacturing functions.
• Or advanced degree with 3+ years in Quality Operations, QC, MSAT, or related functions.
• At least 3 years hands-on experience supporting sterile or aseptic manufacturing environments.
• Experience with authoring and reviewing NDA CMC sections and regulatory filing requirements.
• Ability to work with all levels of the organization and external contract service providers.
• Travel may be required up to 10% within US.

Responsibilities

• Provide quality oversight of Drug Product and Finished Drug Product production activities.
• Review batch production and QC records to ensure procedures are followed and specifications met.
• Prepare and/or approve batch disposition packages.
• Provide QA review and approval on quality system records (deviations, OOS, CAPAs, complaints).
• Lead or participate in QA meetings to ensure GMP/GDP/DDP compliance.
• Write, review and/or approve SOPs as QA SME for manufacturing, labeling, packaging and transport.
• Provide QA review on NDAs and ensure data traceability for regulatory submissions and validation activities.
• Support FDA, EMA, or other regulatory inspections.

Skills

Quality Operations

Quality Control

MSAT

Regulatory filings

NDA/CMC familiarity

Cross-functional collaboration

Regulatory inspections support

Education

Bachelor's degree with 5+ years in pharma QC/operations

Advanced degree (Master's/PhD) with 3+ years

Tools

Documentation systems

Regulatory filing tools

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

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.

We anticipate hiring the Manager, Quality Operations in September 2026.

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.

Required Qualifications

• 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.
• Travel may be required up to 10% within US, which may include on‑site review of third‑party operations.

Preferred Requirements

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

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from 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 and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

Compensation

Estimated Pay Range

$129,000 — $145,000 USD

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.