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.
Top Skills
What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies. We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects. Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction. Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
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