Senior Manager, GCP Quality Assurance

Role Summary

Spyre Therapeutics is a clinical‑stage biotechnology company committed to developing next‑generation therapies that elevate the standard in immunology. The Senior Manager, GCP Quality will support Clinical Quality Assurance activities across Spyre’s clinical development programs, including audits, quality issue management, inspection readiness, and ongoing compliance oversight.

• Provide guidance on GCP, GLP, and GVP requirements to clinical development teams, identifying compliance risks and supporting appropriate mitigations.
• Collaborate with internal stakeholders and external partners, including CROs, vendors, contract auditors, and investigator sites, to support quality oversight and promote consistent compliance.
• Assist in the development and execution of risk‑based audit plans 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 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, 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.

• BA/BS degree in biological sciences or related field.
• Minimum 6+ years of experience in the pharmaceutical, biotechnology, or related healthcare 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 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 collaborative team.
• Travel may be required up to 15% of the time.

Expected salary range: $149,000 to $175,000. Actual pay will vary based on experience, education, and location.

• Opportunity to work in a fast‑paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market‑competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
• Unlimited PTO.
• Two, one‑week company‑wide shutdowns each year.
• Commitment to providing professional development opportunities.
• Remote working environment with frequent in‑person meetings to address complex problems and build relationships.

Spyre is an equal‑opportunity employer committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or other non‑job‑related characteristics, as required by applicable federal, state, and local laws.