Quality Specialist, QMS in Cambridge

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. 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 – create a culture of caring.

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.

Responsibilities:

• Administer document control processes within the eQMS, ensuring effective lifecycle management of controlled documents and records in compliance with quality and regulatory requirements.
• Serve as the subject matter expert for document control processes within the eQMS, providing system administration, user support, and continuous improvement of document management functionality.
• Coordinate and maintain document-related training activities and records to ensure compliance with quality system and regulatory requirements.
• Ensure document control and records management processes support compliance with applicable regulations, quality standards, and audit/inspection readiness requirements.
• Monitor document control performance, identify improvement opportunities, and support initiatives that enhance QMS effectiveness, compliance, and operational efficiency.

Required Qualifications:

• Bachelor's degree
• 1-3 years in pharmaceutical/biotech Quality (GMP environment)
• Experience managing controlled documents and records within an electronic Quality Management System (eQMS), including experience with Veeva Vault Quality Docs/Veeva Vault Quality.
• Working knowledge of Quality Management Systems (QMS), document control principles, records management, and Good Documentation Practices (GDocP).
• Understanding of GxP regulations, data integrity requirements, and industry standards applicable to biopharmaceutical organizations.
• Experience supporting quality audits, regulatory inspections, and compliance activities in a regulated environment.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities while meeting deadlines.
• Strong analytical, problem-solving, written, and verbal communication skills, with the ability to work effectively across cross-functional teams.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Teams).

Preferred Requirements:

• Certification in Quality, Records Management, or a related discipline.
• Experience supporting eQMS implementation, validation, system administration, or continuous improvement initiatives.

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 a 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:

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. Estimated Pay Range: $82,000 - $92,000 USD.

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, colour, 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.