Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases.
Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
Alumis is hiring a Clinical Quality Assurance Sr. Director, reporting to the VP of Quality. The role will work closely with the Development leadership and Study Execution Team members to provide GCP / GVP support for all ongoing clinical studies.
This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.
The Clinical QA Sr. Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations.
The Sr. Director will be responsible to establish Key Performance Indicators and Metrics to trend and track the health of the clinical trials.
The role is responsible for providing operational quality guidance for the development teams and supporting the VP of Quality in building the Alumis Quality organization strategy and vision.
This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations.
The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management.
The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.
Essential Duties & Responsibilties
- 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 the Health Authority and internal / external business partners.
- Support clinical service provider selection and qualification activities and develop periodic compliance / metric reports.
Education & Experience
- Bachelors or advanced degree in Biology, Chemistry, or related field.
- Minimum 12 years of GCP / GVP Quality Assurance experience.
- Strong understanding of small molecule products with direct experience in solid oral dosage forms.
Knowledge Skills Abilities
- Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
- Hands-on experience in drug life cycle management.
- A successful track record of working with service providers and CROs.
- Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations.
Highly skilled in the ability to work with ambiguity and complexity.
- Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
- Excellent verbal and written communication skills.
- Collaborative, analytical and interpretative skills.
- Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
- Previous experience in successfully leading assigned activities within cross-functional teams.
- Some travel is required.
Alumis Values
- Elevate
- Challenge
- Nurture
This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday.
At this time we are not considering remote applicants.
The salary range for this position is $260,000 USD to $275,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.
Alumis Inc. is an equal opportunity employer.
Director, Quality Assurance
The Director, Quality Assurance will lead all quality activities at Karius. Quality Management, Quality Assurance, and Quality Control leadership experience in Diagnostics, Biotechnology, or relatable life sciences fields. This person will additionally define and build the quality team, and lead the...
Director of the UCSF Airway Clinical Research Center (ACRC)
The Department of Medicine, Division of Pulmonary, Critical Care, Allergy and Sleep Medicine and the Cardiovascular Research Institute (CVRI) are seeking a Director of the UCSF Airway Clinical Research Center (ACRC) for a full-time faculty position. The appointment will be made at the level of Assis...
Senior Director, Clinical Safety Science
Lead and/or participates in the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety)/Common Technical Document (CTD) submissions and other documents as needed; ensure...
Director of Population Health & Quality Improvement
The Director of Population Health and Quality Improvement (DPHQI) will be primarily responsible for leading efforts to improve both population health outcomes and clinical quality, while enhancing satisfaction for patients and staff. The DPHQI will work closely with the Director of Clinical Operatio...
Regional Director of Sales
Director of Corporate Sales, the RSD works closely with community Executive Directors, Regional Director of Operations, and corporate team members to focus on the appropriate priorities to ensure the appropriate objectives and goals are achieved within the community sales team (Senior Lifestyle Coun...
Senior Director of Product Marketing
We are seeking a dynamic and experienced Senior Director of Product Marketing to lead our product marketing efforts at OpenGov. As the Senior Director, you will be responsible for developing and executing strategic marketing plans that drive awareness, adoption, and revenue growth for our suite of p...
Associate Director, Clinical Quality Assurance
Previous Quality Assurance experience (5+ years) in clinical research /development preferred• Minimum of 5-7 years of Quality Assurance auditing experience. Leads the implementation of quality standards, policies, and procedures in compliance with applicable ICH-GCP regulations and guidelines• Assis...
Data Quality Engineer, Senior
The Data Services Quality Engineering team is part of the BSC Data & Analytics Organization. The Quality Enginer, Senior will report to the IT Manager. Follow best practices and maintain quality assurance standards. Quality Engineering experience, with 4 years of experience in Data Warehousing prefe...
Senior Scientific Director, Toxicology
Evaluate, interpret and summarize toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy. Senior Scientific Director, Toxicology - San Diego, CA (Hybrid). Represe...
Senior Director of Nonprofit Accounting
Senior Director of Nonprofit Accounting to provide strategic leadership and financial management services to the nonprofit clients of a reputable midsized public accounting firm. Scion Nonprofit Staffing is an award-winning national nonprofit recruitment and staffing specialist for nonprofit organiz...