Director of Clinical Quality Assurance
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
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 Director, reporting to the SVP,
of Quality and Regulatory. The role will work closely with the
Quality, Development, and Study Execution Teams to provide Clinical
Quality 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 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
Director will be responsible to establish Key Performance
Indicators and Metrics to trend and track on the health of the
clinical trials. The role is responsible to provide the operational
quality support and guidance for the development teams and support
the SVP of Quality and Regulatory in building the Alumis Quality
organization strategy and vision. This position requires expertise
in Good Clinical Practices 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 & RESPONSIBILITIES Establish,
maintain and enhance 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/CSV
related matters and issues for the assigned program, project or
study. Establish the study specific audit plan ensuring successful
execution and audit findings close out including CAPA management
and oversight. Establish and manage the Quality Risk Management
program. Represent Quality on project teams, Health Authority
Inspections, service providers and CROs operational meetings, and
QA to QA meetings. Support Quality Review meetings content and
material. Prepare and manage Quality 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.
Partner in implementation of inspection readiness plans and
activities. Act as the primary liaison with Development and
Compliance team in execution of inspection and audit readiness
plans including for internal/external and business partners audits.
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 10 years of Clinical 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, to motivate and influence others.
Prior management experience is required. Previous experience in
successfully leading assigned activities within cross-functional
teams. Some travel required. The salary range for this position is
$190,000 USD to $240,000 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. Lab personnel, however, are generally onsite 4-5
days/week. At this time we are not considering remote applicants.
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: Health
insurance premiums paid at 90% for employee, 80% for dependents
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 yummy 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.
Keywords: , San Bruno , Director of Clinical Quality Assurance, Science, Research & Development , South San Francisco, California
