Full Job Description
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.
• 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
Skills and experience you'll bring:
• 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
• Experience supporting regulatory inspection readiness activities is a plus
• 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
Compensation
• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $85,000 - $200,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.