Senior Director, 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 Sr. Director, reporting to the
SVP 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. 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. This position is located
in South San Francisco, CA and employees are expected to be onsite
Tuesday-Thursday.* 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. *Lab personnel are generally onsite 4-5
days/week.
Keywords: , Woodland , Senior Director, Clinical Quality Assurance, Science, Research & Development , South San Francisco, California
