Senior Specialist or Manager, Quality Systems
Kymera Therapeutics
August 08, 2026
Remote friendly (Greater Boston)
United States
Operations
How you’ll make an impact:
The Quality Systems role is responsible for managing the operational infrastructure of Kymera's Quality Management System, with primary ownership of document control, training program management, and quality systems compliance monitoring. Ensures GxP-controlled documents, SOPs, and personnel training records are accurately maintained and compliant with applicable regulatory requirements.
Key responsibilities:
- Administer and maintain Document Control and Training eQMS (Veeva Vault)
- Manage document lifecycle: review/approval workflows, archiving, retrieval, and biennial review across all GxP functions
- Develop/maintain role-based GxP training curricula; assign training tasks upon document approval; monitor compliance
- Track and report QMS metrics to support Quality Management Review and executive reporting
- Maintain inspection-ready training records, document retrieval indexes, and controlled document inventories
- Contribute to development/revision/lifecycle management of Quality System SOPs and policies
- Maintain vendor qualification records and Approved Supplier List
- Support quality systems compliance monitoring and continuous improvement of QMS infrastructure
Skills and experience you’ll bring:
- Bachelor’s degree in Life Sciences (or related field) required
- 5+ years in Quality Systems, Document Control, or GxP Quality in a sponsor organization
- Hands-on experience administering an electronic document management/eQMS platform
- Experience managing GxP training programs (curriculum, training matrix, compliance tracking)
- Working knowledge of 21 CFR Part 11 and ICH E6(R3); GxP document control and training
- Familiarity with CAPA, deviations, audits, and vendor qualification
- Proficient in Veeva Vault; Microsoft Office (Word/Excel/PowerPoint)
- Strong organizational skills; high attention to detail; clear communication; self-directed
Preferred:
- Experience supporting regulatory inspection readiness activities
Compensation (as stated):
- Anticipated base salary range: $85,000–$200,000; eligibility for annual bonus, equity participation, and comprehensive benefits
The Quality Systems role is responsible for managing the operational infrastructure of Kymera's Quality Management System, with primary ownership of document control, training program management, and quality systems compliance monitoring. Ensures GxP-controlled documents, SOPs, and personnel training records are accurately maintained and compliant with applicable regulatory requirements.
Key responsibilities:
- Administer and maintain Document Control and Training eQMS (Veeva Vault)
- Manage document lifecycle: review/approval workflows, archiving, retrieval, and biennial review across all GxP functions
- Develop/maintain role-based GxP training curricula; assign training tasks upon document approval; monitor compliance
- Track and report QMS metrics to support Quality Management Review and executive reporting
- Maintain inspection-ready training records, document retrieval indexes, and controlled document inventories
- Contribute to development/revision/lifecycle management of Quality System SOPs and policies
- Maintain vendor qualification records and Approved Supplier List
- Support quality systems compliance monitoring and continuous improvement of QMS infrastructure
Skills and experience you’ll bring:
- Bachelor’s degree in Life Sciences (or related field) required
- 5+ years in Quality Systems, Document Control, or GxP Quality in a sponsor organization
- Hands-on experience administering an electronic document management/eQMS platform
- Experience managing GxP training programs (curriculum, training matrix, compliance tracking)
- Working knowledge of 21 CFR Part 11 and ICH E6(R3); GxP document control and training
- Familiarity with CAPA, deviations, audits, and vendor qualification
- Proficient in Veeva Vault; Microsoft Office (Word/Excel/PowerPoint)
- Strong organizational skills; high attention to detail; clear communication; self-directed
Preferred:
- Experience supporting regulatory inspection readiness activities
Compensation (as stated):
- Anticipated base salary range: $85,000–$200,000; eligibility for annual bonus, equity participation, and comprehensive benefits