Spyre Therapeutics
Senior Manager, GCP Quality Assurance
Remote, USA · Senior
Sponsorship not specified$149k-$175kDetected 13 days ago
GCPFDA RegulatoryPharmacovigilanceMedical DevicesCommunicationProblem SolvingOrganizational SkillsGxPRegulatory Affairs
About the role
- 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 expected salary range offer for this role is $149,000 to $175,000.
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.
- Support investigations related to quality events, protocol deviations, compliance concerns, and potential GCP/GLP/GVP issues
- 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
- 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.
Requirements
- BA/BS degree, preferably in biological sciences, or related field
- Travel may be required up to 15% of the time
Nice to have
- Experience supporting regulatory inspections and inspection readiness activities preferred.
Compensation
- The expected salary range offer for this role is $149,000 to $175,000.
Benefits
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
Equal opportunity
- As an equal opportunity employer, Spyre is committed to a diverse workforce.
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This listing is sourced directly from Spyre Therapeutics's careers page and normalized into a canonical job model.