Specialist/Manager, Quality Systems

Kymera Therapeutics•Watertown, MA

7d•$85,000 - $200,000

About The Position

The Manager/Specialist, Quality Systems 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. This role ensures that GxP-controlled documents, SOPs, and personnel training records are accurately maintained and compliant with applicable regulatory requirements. The individual will play a key role in sustaining day-to-day QMS operations, managing the controlled document lifecycle including biennial review programs, driving training compliance across the organization, and supporting quality systems performance monitoring as Kymera advances late-stage development and commercialization.

Requirements

Bachelor's degree in Life Sciences, or related field required
5+ years of experience in Quality Systems, Document Control, or GxP Quality in a sponsor organization
Hands-on experience administering an electronic document management or eQMS platform
Experience managing GxP training programs including curriculum maintenance, training matrix administration, and compliance tracking in a regulated environment
Working knowledge of 21 CFR Part 11, ICH E6(R3), and GxP document control and training
Familiarity with quality systems elements including CAPA, deviations, audits, and vendor qualification
Strong organizational skills with ability to manage multiple concurrent document workflows and priorities in a fast-paced environment
High attention to detail, clear written and verbal communication skills with ability to engage cross-functional stakeholders at all levels
Self-directed with ability to prioritize workload and escalate appropriately
Proficient in Veeva Vault, Microsoft Office suite including Word, Excel, and PowerPoint

Nice To Haves

Experience supporting regulatory inspection readiness activities is a plus

Responsibilities

Administer and maintain Kymera's Document Control and Training electronic Quality Management System (Veeva Vault)
Manage document lifecycle, review/approval workflows, archiving, retrieval and biennial review across all GxP functions
Develop and maintain role-based GxP training curricula, assign training tasks upon document approval, and monitor compliance across the organization to meet defined quality objectives
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 the development, revision, and lifecycle management of Quality System SOPs and policies in alignment with Kymera's QMS
Maintain vendor qualification records and Approved Supplier List
Support quality systems compliance monitoring activities and contribute to continuous improvement of QMS infrastructure as Kymera scales towards late stage and commercialization