Senior Manager, GCP Quality Assurance

## About the Role The Senior Manager, GCP Quality Assurance at Spyre Therapeutics plays a pivotal role in ensuring the company's clinical development programs adhere to the highest standards of quality and compliance. This involves working closely with various teams, including Clinical Operations, Clinical Development, and Regulatory Affairs, to promote a culture of quality across all aspects of clinical trial management. The successful candidate will have a deep understanding of Good Clinical Practice (GCP) regulations and quality systems, as well as the ability to lead and collaborate effectively.

Day-to-day, this role entails managing and supporting Clinical Quality Assurance (CQA) activities across Spyre's clinical development programs. This includes planning and executing audits, managing quality issues and investigations, and ensuring inspection readiness. The Senior Manager will also provide guidance on GCP, Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) requirements to clinical development teams, helping identify compliance risks and implement appropriate mitigations.

Spyre Therapeutics is committed to delivering next-generation therapies that elevate the standard in immunology. As part of this mission, the Senior Manager, GCP Quality Assurance will contribute to ensuring that all clinical trials are conducted with the utmost integrity and adherence to regulatory requirements, ultimately contributing to the development of innovative treatments for patients.

## What You Will Do - Provide guidance and support on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) requirements to clinical development teams.

• Collaborate with internal stakeholders and external partners 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.
• 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.
• 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.

## What We Are Looking For - BA/BS degree, preferably in biological sciences or a related field.

• Minimum of 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, and EMA requirements.
• Excellent collaboration and leadership skills, with the ability to work effectively across functions.
• Proficiency in Excel and other relevant software tools.
• Experience with quality management systems and audit management processes.
• Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements.

## Nice to Have - Experience with clinical trial management systems and electronic data capture tools.

• Knowledge of regulatory requirements in multiple regions, including the US, EU, and others.
• Certification in clinical research or a related field, such as CCRA or CCRP.
• Experience with process improvement initiatives and change management.

## Benefits and Perks - Competitive salary and benefits package.

• Opportunity to work on innovative, next-generation immunology therapies.
• Collaborative and dynamic work environment with a team of experienced professionals.
• Flexible remote work arrangements, with the opportunity to work from anywhere in the United States.
• Professional development opportunities, including training and conference attendance.
• Access to the latest tools and technologies in clinical trial management and quality assurance.
• Comprehensive health insurance and retirement savings plan.
• Generous paid time off and holiday schedule.

- Ensure your resume and cover letter highlight your experience with GCP regulations and quality systems, as well as your ability to collaborate and lead effectively.

• Be prepared to provide specific examples of your experience with audits, quality issues, and compliance management during the interview process.
• Familiarize yourself with Spyre Therapeutics' pipeline and mission, and be ready to discuss how your skills and experience align with the company's goals.
• Consider obtaining or highlighting any relevant certifications, such as CCRA or CCRP, to demonstrate your expertise in clinical research.
• When negotiating salary, be sure to research the market average for similar roles in the biotech industry and be prepared to discuss your expectations.
• Pay close attention to the company culture and values during the interview process, and be sure to ask about opportunities for professional development and growth.