Spyre Therapeutics · 12 hours ago
Manager, Quality Systems
United States
Full-time
Remote
Mid, Senior Level
$140K/yr - $151K/yr
5+ years expSpyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. The Manager, Quality Management Systems will contribute to maintaining Spyre’s Quality Management System and drive improvements to GxP quality systems and processes while collaborating with various functional teams.
BiotechnologyTherapeutics
Responsibilities
Manage and maintain a compliant Document Control System (Veeva)
Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product quality related documents) and archiving activities
Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for each function and reporting monthly metrics
Manage the processing of QMS items for Change Control, Deviations and CAPAs
Generate Quality System metrics as per established timelines and assist in generating data for Quality Management Reviews
Work with document authors and reviewers to process documents
Oversee periodic document review process to ensure compliance with established review schedules
Onboarding/Offboarding employees and assigning training
Train and mentor users on the use of eQMS, process and procedures
Support Spyre functional groups as needed
Other duties as assigned
Qualification
Required
Bachelor's degree in life sciences or a related field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality control/quality assurance functions
Experience in the use of Veeva electronic quality management systems (eQMS) (Veeva Vault or Veeva Quality Basics) required
In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits
Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously
Strong verbal / written communication and presentation skills with the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations
Demonstrated ability to work in a fluid, dynamic and fast-paced environment
Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook
Preferred
Experience with monoclonal antibodies is preferred
Benefits
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Company
Spyre Therapeutics
Spyre Therapeutics is a biotechnology business that is developing a strong pipeline of antibody therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$835M2025-10-13Post Ipo Equity· $275M
2024-11-18Post Ipo Equity· $200M
2024-03-18Post Ipo Equity· $180M
Leadership Team
Kate Chevlen
Chief Commercial Officer
Sheldon Sloan
Chief Medical Officer
Recent News
thefly.com
2026-01-03
2025-12-01
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