Specialist, Quality Management Systems (QMS)

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

• Document Control Management
• Administer document control processes within the eQMS, ensuring effective lifecycle management of controlled documents and records in compliance with quality and regulatory requirements.
• eQMS Administration and Support
• 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.
• Training Management and Compliance
• Coordinate and maintain document-related training activities and records to ensure compliance with quality system and regulatory requirements.
• Compliance and Inspection Readiness
• Ensure document control and records management processes support compliance with applicable regulations, quality standards, and audit/inspection readiness requirements.
• Metrics, Continuous Improvement, and QMS Support
• Monitor document control performance, identify improvement opportunities, and support initiatives that enhance QMS effectiveness, compliance, and operational efficiency.

• 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 setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.

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 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.