Senior Manager, GCP Quality Assurance

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

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

Ideal Candidate

BA/BS degree, preferably in biological sciences, or related field

Minimum of 6+ years of experience in the pharmaceutical, biotechnology or related health care industry

Minimum 4+ years of GCP-related Quality Assurance or relevant clinical trial and medical device experience

Strong knowledge of ICH-GCP, GLP, GVP, FDA regulations, EMA requirements, and other applicable global clinical development regulations and guidelines.

Experience conducting and/or managing GCP audits of investigator sites, vendors, CROs, and clinical systems.

Experience supporting regulatory inspections and inspection readiness activities preferred.

Working knowledge of Quality Management Systems, including CAPA, deviation management, risk assessment, change control, document management, and training systems.

Demonstrated ability to analyze regulations and apply quality and compliance principles in a practical, risk-based manner.

Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Excellent written and verbal communication skills and the ability to effectively collaborate across functions and organizational levels.

Detail-oriented with strong problem-solving and critical-thinking capabilities.

Ability to work independently while also contributing effectively as a member of a c…