Cambridge, Massachusetts, United States · Remote OK
$82k–$92k/yr
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 commitmen…
Skills: Document Control, QMS, GxP, Veeva Vault Quality, Records Management
Cambridge, Massachusetts, United States · Hybrid
$314k–$353k/yr
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 commitmen…
Skills: Regulatory Affairs, Advertising and Promotion, FDA Regulations, OPDP, Strategic Leadership
Cambridge, Massachusetts, United States · Hybrid
$163k–$183k/yr
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 commitmen…
Skills: Payroll Administration, Equity Administration, ADP Workforce Now, Shareworks, Computershare
Cambridge, Massachusetts, United States · Hybrid
$65k–$73k/yr
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 commitmen…
Skills: Accounts Payable, NetSuite, Concur, Invoice Processing, Expense Auditing
Cambridge, Massachusetts, United States · Hybrid
$269k–$292k/yr
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 commitmen…
Skills: Nonclinical Safety Strategy, Toxicology, Regulatory Submissions, CRO Management, Risk-Benefit Assessment
Cambridge, Massachusetts, United States · Remote OK
$186k–$209k/yr
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 commitmen…
Skills: Discovery pharmacology, Drug discovery, Pharmacology strategy, Small molecules, Peptides
Cambridge, Massachusetts, United States · Hybrid
$223k–$265k/yr
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 commitmen…
Skills: National Payer Strategy, PBM Relationship Management, Rare Disease Reimbursement, Coverage Policy Development, Utilization Management
Cambridge, Massachusetts, United States · Hybrid
$298k–$335k/yr
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 commitmen…
Skills: Healthcare Compliance, Program Design, Risk Assessment, Regulatory Compliance, Strategic Planning
Cambridge, Massachusetts, United States · Hybrid
$248k–$279k/yr
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 commitmen…
Skills: Thought Leader Engagement, KOL Identification, Regional Marketing, Strategic Planning, Cross-functional Leadership
Cambridge, Massachusetts, United States · Hybrid
$176k–$198k/yr
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 commitmen…
Skills: Contract Negotiation, Healthcare Compliance, Employment Law, Risk Management, Litigation Management
Cambridge, Massachusetts, United States · Hybrid
$188k–$212k/yr
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 commitmen…
Skills: Inventory Accounting, Cost Accounting, U.S. GAAP, NetSuite, Standard Costing
Cambridge, Massachusetts, United States · Hybrid
$236k–$266k/yr
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 commitmen…
Skills: Revenue Accounting, Gross-to-Net Operations, Government Pricing Compliance, US GAAP, SOX Compliance
Cambridge, Massachusetts, United States · Hybrid
$211k–$237k/yr
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 commitmen…
Skills: Medical Information Strategy, Inquiry Management, Vendor Management, Content Strategy, Launch Readiness
Cambridge, Massachusetts, United States · Hybrid
$173k–$195k/yr
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 commitmen…
Skills: Media Strategy, Omnichannel Engagement, Digital Marketing, Budget Management, Marketing Analytics
Cambridge, Massachusetts, United States · Hybrid
$140k–$158k/yr
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 commitmen…
Skills: Marketing Operations, Project Management, Budget Management, Vendor Management, Event Operations
Cambridge, Massachusetts, United States · Hybrid
$125k–$141k/yr
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 commitmen…
Skills: Purchase Order Management, Supplier Master Data Maintenance, Procure to Pay (P2P), Purchasing Data Analysis, SOX Compliance
Cambridge, Massachusetts, United States · Remote OK
$253k–$285k/yr
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 commitmen…
Skills: Patient support services, Product launch, Rare disease, Hub services, Reimbursement support
Cambridge, Massachusetts, United States · Hybrid
$221k–$249k/yr
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 commitmen…
Skills: Biostatistics, Clinical Trial Design, SAS, R, CDISC Standards
Cambridge, Massachusetts, United States · Hybrid
$172k–$194k/yr
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 commitmen…
Skills: Quality Operations, CMC Quality Oversight, GMP Compliance, GDP Compliance, Regulatory Filing
Cambridge, Massachusetts, United States · Hybrid
$129k–$145k/yr
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 commitmen…
Skills: IT Infrastructure Management, ITIL Service Operations, Azure/Entra ID, Office 365, SharePoint Online
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The Quality Specialist is responsible for the administration, maintenance, and continuous improvement of document control processes within the Quality Management System. This role ensures effective lifecycle management of controlled documents while supporting cross-functional teams and maintaining inspection readiness.
Candidates must hold a bachelor's degree and possess 1-3 years of experience in pharmaceutical or biotech Quality within a GMP environment. Proficiency in electronic Quality Management Systems (eQMS), specifically Veeva Vault, and a strong understanding of GxP regulations are required.
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 Specialist, Quality Management Systems (QMS) – Document Control is responsible for the administration, maintenance, and continuous improvement of the organization's document control processes within the Quality Management System. This role ensures the effective lifecycle management of controlled documents and records in compliance with applicable GxP regulations, company policies, and industry standards.
The Specialist serves as a key business partner to cross-functional teams, supporting the creation, review, approval, distribution, training, and archival of controlled documents while maintaining inspection readiness and promoting operational excellence across the organization.
We anticipate hiring the Quality Specialist, QMS in September 2026
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.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
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.
Ushering in a new era for treating diseases with high unmet needs
We have an audacious mission to develop novel therapies for communities with high unmet needs. Where others see challenges, Amylyx sees opportunities that we pursue with urgency, rigorous science, and unwavering commitment. We explore scientific approaches that are tailored to diseases where we can make the greatest difference, agnostic of modality, in order to usher in a new era of advancements. See our community guidelines here: https://www.amylyx.com/social-media-guidelines Please be aware of potential phishing scams imitating Amylyx. All authentic communications from Amylyx will be from the Amylyx.com domain.
Offices: Cambridge, MA 02141, US
Ushering in a new era for treating diseases with high unmet needs
We have an audacious mission to develop novel therapies for communities with high unmet needs. Where others see challenges, Amylyx sees opportunities that we pursue with urgency, rigorous science, and unwavering commitment. We explore scientific approaches that are tailored to diseases where we can make the greatest difference, agnostic of modality, in order to usher in a new era of advancements. See our community guidelines here: https://www.amylyx.com/social-media-guidelines Please be aware of potential phishing scams imitating Amylyx. All authentic communications from Amylyx will be from the Amylyx.com domain.
Offices: Cambridge, MA 02141, US
