Director, GCP Compliance
Company: Alumis Inc.
Location: South San Francisco
Posted on: March 11, 2026
|
|
|
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. Director, GCP
Compliance 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.
Reporting to the Executive Director, GCP Compliance, the Director
of GCP Compliance serves as a strategic leader responsible for GCP
oversight, Inspection Readiness (IR), and cross-functional quality
partnership. This role provides GCP Compliance direction for
clinical programs, advances clinical process excellence, and
ensures development programs operate with the highest standards of
quality, compliance, and inspection readiness. Strategic Priorities
Lead Inspection Readiness (IR) strategy and execution across
assigned clinical programs, ensuring teams are prepared for
regulatory engagement. Serve as a strategic partner to QA,
collaborating on compliance risk mitigation, quality signals, and
inspection readiness activities. Provide strategic oversight for
issue management across clinical programs, ensuring GCP issues are
identified, assessed, escalated, and resolved with urgency and
transparency. Drive the development and reporting of compliance
metrics, dashboards, and tools that enable clear, data?driven
quality decisions. Champion a culture of quality and compliance
within Development, serving as a visible advocate in partnership
with QA. Operational Responsibilities Lead GCP training
initiatives, including development and delivery, ensuring content
is current, impactful, and aligned with organizational growth.
Support the evolution of Clinical Study Management processes to
align with regulatory expectations and operational excellence.
Partner with Development Operations, Biometrics, Pharmacovigilance,
QA, and Regulatory Affairs to proactively identify and mitigate
compliance risks. Develop and deliver GCP training programs for
internal teams and external partners to champion a quality-first
mindset, reinforcing consistent compliance behaviors. Support
initiatives that reinforce strong procedural compliance across
clinical programs Collaborate with QA on deviation management,
CAPAs and audit/inspection finding resolution and close out. The
Ideal Candidate Holds an advanced degree in Life Sciences,
Pharmacy, or related field is preferred. Brings 10 years of
experience in GCP quality/compliance, including 3 years in a
leadership role. Possesses deep knowledge of ICH-GCP, FDA, EMA, and
other global regulatory requirements. Demonstrates proven success
supporting or leading inspection readiness and serving as an
interface with global health authorities during inspections.
Communicates with clarity, leads with influence, and builds trust
across teams. Experience in biotech or pharmaceutical industry,
ideally in late-stage clinical development. Combines strategic
insight with strong operational execution, translating executive
direction into clear, actionable initiatives. Acts with high
integrity and commitment to ethical research practices; able to
navigate complex regulatory and organizational environments. Leads
with collaboration and agility, fostering strong relationships and
effective decision?making across the organization. This position is
located in South San Francisco, CA, with an expectation to be
on-site Tuesday through 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. The salary range for this position is $200,500 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. 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: Alumis Inc., South San Francisco , Director, GCP Compliance, Science, Research & Development , South San Francisco, California