Senior Manager, GCP Quality Assurance

Role Summary

Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The Senior Manager, GCP Quality will support Clinical Quality Assurance (CQA) activities across Spyre’s clinical development programs, including the planning and execution of audits, management of quality issues and investigations, inspection readiness activities, and ongoing compliance oversight. This role requires strong knowledge of GCP regulations and quality systems, as well as the ability to collaborate effectively across functions to promote a culture of quality and continuous improvement.

The Senior Manager will partner closely with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to ensure compliance with Spyre policies, procedures, and applicable global regulations and guidelines, including FDA, EMA, ICH, and other relevant regulatory requirements.

Key Responsibilities

• Provide guidance and support on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) requirements to clinical development teams, helping identify compliance risks and support implementation of appropriate mitigations.
• Collaborate with internal stakeholders and external partners, including CROs, vendors, contract auditors, and investigator sites, to support quality oversight activities and promote consistent compliance across development programs.
• Assist in the development and execution of risk-based audit plans for assigned programs and support inspection readiness initiatives.
• Independently plan, conduct, manage, and report domestic and international audits of investigator sites, vendors, systems, and processes in accordance with applicable regulations and Spyre procedures.
• Evaluate audit observations and quality issues for potential impact on participant safety, data integrity, and regulatory compliance.
• Support investigations related to quality events, protocol deviations, compliance concerns, and potential GCP/GLP/GVP issues; assist with root cause analysis, CAPA development, implementation, and effectiveness verification.
• Contribute to health authority inspection readiness activities and provide quality support during regulatory inspections and vendor audits.
• Track, analyze, and communicate quality metrics and trends to support continuous improvement and risk management activities.
• Partner with the broader Quality organization to identify opportunities for process improvements and harmonization across programs and functional areas.
• Support the maintenance and continuous improvement of Spyre’s Quality Management System (QMS), including procedures, training, CAPA, and audit management processes.
• Maintain awareness of evolving regulatory requirements and industry best practices and help ensure appropriate implementation within the organization
• Other duties as assigned