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← Amylyx Pharmaceuticals

Specialist, QMS – Document Control

Amylyx Pharmaceuticals
Location
Cambridge, MA
Posted
1 month ago
Department
220 - Quality Operations
What they actually want (must-haves)
  • 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
Nice to have
  • Certification in Quality, Records Management, or a related discipline
  • Experience supporting eQMS implementation, validation, system administration, or continuous improvement initiatives
What the job really is

The Specialist, QMS – Document Control is responsible for managing the document control processes within the Quality Management System at Amylyx. This includes ensuring compliance with GxP regulations, supporting cross-functional teams in document lifecycle management, and maintaining inspection readiness. The role also involves training management, continuous improvement of document management functionality, and monitoring document control performance.

Things to weigh
  • Remote work opportunities available, but not open to applicants from certain states (Alaska, Arizona, Hawaii, Michigan, Tennessee)
  • Travel to Cambridge, MA several times a year is required
  • Pay range is estimated and may vary based on experience and qualifications
Job score2.2/5
Benefits1/5
Freshness3/5
Career value3/5
Role clarity4/5
Pay transparency0/5

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