Director, GCP Compliance
About The Position
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.
Requirements
- 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.
Responsibilities
- 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.
- 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.
Benefits
- Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.
- 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!
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What This Job Offers
Job Type
Full-time
Career Level
Director
