Senior Specialist or Manager, Quality Systems
Kymera Therapeutics
August 29, 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 (QMS), 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.
Responsibilities:
- Administer and maintain Document Control and Training eQMS platform (Veeva Vault)
- Manage controlled 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 training 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
Qualifications/Skills:
- Bachelor’s degree in Life Sciences (or related field) required
- 5+ years in Quality Systems, Document Control, or GxP Quality (sponsor organization)
- Hands-on experience administering an electronic document management/eQMS platform
- Experience managing GxP training programs (curriculum, training matrices, compliance tracking)
- Working knowledge of 21 CFR Part 11, ICH E6(R3), and GxP document control/training
- Familiarity with CAPA, deviations, audits, and vendor qualification
- Experience supporting regulatory inspection readiness (plus)
- Strong organization; manage multiple document workflows in a fast-paced environment
- High attention to detail; clear written/verbal communication with cross-functional stakeholders
- Self-directed; prioritize and escalate appropriately
- Proficient in Veeva Vault and Microsoft Office (Word, Excel, PowerPoint)
Compensation/Benefits:
- 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 (QMS), 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.
Responsibilities:
- Administer and maintain Document Control and Training eQMS platform (Veeva Vault)
- Manage controlled 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 training 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
Qualifications/Skills:
- Bachelor’s degree in Life Sciences (or related field) required
- 5+ years in Quality Systems, Document Control, or GxP Quality (sponsor organization)
- Hands-on experience administering an electronic document management/eQMS platform
- Experience managing GxP training programs (curriculum, training matrices, compliance tracking)
- Working knowledge of 21 CFR Part 11, ICH E6(R3), and GxP document control/training
- Familiarity with CAPA, deviations, audits, and vendor qualification
- Experience supporting regulatory inspection readiness (plus)
- Strong organization; manage multiple document workflows in a fast-paced environment
- High attention to detail; clear written/verbal communication with cross-functional stakeholders
- Self-directed; prioritize and escalate appropriately
- Proficient in Veeva Vault and Microsoft Office (Word, Excel, PowerPoint)
Compensation/Benefits:
- Anticipated base salary range: $85,000–$200,000; eligibility for annual bonus, equity participation, and comprehensive benefits.