Senior Director of Clinical Quality Assurance
Alumis, South San Francisco, California, us, 94083
Senior Director of Clinical Quality Assurance
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Alumis is hiring a Senior Director of Clinical Quality Assurance, reporting to the Executive Director, GCPQA. The role collaborates with Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for ongoing clinical studies and works with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Senior Director of Clinical QA ensures quality is embedded throughout the lifecycle of all ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. The role leads KPIs and metrics to trend and track the health of clinical trials. It provides operational quality guidance for development teams and supports the Executive Director of GCP Quality in building Alumis Quality organization strategy and vision. This position requires expertise in Good Clinical and Pharmacovigilance Practices and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management, and provide guidance to maintain the standards expected by global regulatory authorities. ESSENTIAL DUTIES & RESPONSIBILITIES
Establish and maintain the GCP QA programs, policies, and procedures. Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines. Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues. Establish the study specific audit plan; perform audits and lead a team of external quality auditors as needed. Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings. Manage Quality Review Board meetings content and material. Prepare KPI and metrics. Provide quality oversight and review of key Clinical and IND/NDA enabling documents. Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues. Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with Health Authority and internal/external business partners. Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports. EXPERIENCE
Minimum 12 years of GCP/GVP Quality Assurance experience. Strong understanding of small molecule products with direct experience in solid oral dosage forms. EDUCATION
Bachelor’s or advanced degree in Biology, Chemistry, or related field. The salary range for this position is $236,000 USD to $295,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with snacks and drinks We are a hard-working, collaborative team on a mission to transform patient’s lives and we aspire to elevate, challenge and nurture one another along the way.
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Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Alumis is hiring a Senior Director of Clinical Quality Assurance, reporting to the Executive Director, GCPQA. The role collaborates with Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for ongoing clinical studies and works with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Senior Director of Clinical QA ensures quality is embedded throughout the lifecycle of all ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. The role leads KPIs and metrics to trend and track the health of clinical trials. It provides operational quality guidance for development teams and supports the Executive Director of GCP Quality in building Alumis Quality organization strategy and vision. This position requires expertise in Good Clinical and Pharmacovigilance Practices and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management, and provide guidance to maintain the standards expected by global regulatory authorities. ESSENTIAL DUTIES & RESPONSIBILITIES
Establish and maintain the GCP QA programs, policies, and procedures. Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines. Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues. Establish the study specific audit plan; perform audits and lead a team of external quality auditors as needed. Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings. Manage Quality Review Board meetings content and material. Prepare KPI and metrics. Provide quality oversight and review of key Clinical and IND/NDA enabling documents. Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues. Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with Health Authority and internal/external business partners. Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports. EXPERIENCE
Minimum 12 years of GCP/GVP Quality Assurance experience. Strong understanding of small molecule products with direct experience in solid oral dosage forms. EDUCATION
Bachelor’s or advanced degree in Biology, Chemistry, or related field. The salary range for this position is $236,000 USD to $295,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: Free access to Genentech Bus & Ferry Share program $100 monthly cell phone stipend Unlimited PTO for Exempt employees Free onsite gym and a kitchen stocked with snacks and drinks We are a hard-working, collaborative team on a mission to transform patient’s lives and we aspire to elevate, challenge and nurture one another along the way.
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