Senior Manager, GCP Quality Assurance

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Spyre Therapeutics

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11 - 50 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🏭 Fertigung

Healthcare • Consulting • Manufacturing

Spyre Therapeutics ist ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung von Therapien für entzündliche Darmerkrankungen (IBD) konzentriert. Das Unternehmen setzt sich dafür ein, erstklassige Antikörper, rationale therapeutische Kombinationen und präzise Immunologieansätze zu schaffen, um die Wirksamkeit und den Komfort der Behandlung für IBD-Patienten zu verbessern. Mit einem erfahrenen Team, das Behandlungen für verschiedene Krankheiten entwickeln und vermarkten kann, widmet sich Spyre Therapeutics der Verbesserung von Behandlungsoptionen und Ergebnissen für Patienten durch fortgeschrittene Forschung in der Immunologie. Das Unternehmen fördert ein kooperatives und innovatives Umfeld, um seine Mission zu erreichen, vielversprechende neue Behandlungsoptionen für IBD bereitzustellen.

Beschreibung

• 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

🎯 Anforderungen

• 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 collaborative team. • Travel may be required up to 15% of the time.

🏖️ Vorteile

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.