Director, GCP Compliance
$200.5k/y-$240k/y
BioSpace17 hours ago
Highlight
OnsiteFull-timeDirector
Summary
Alumis Inc. is seeking a Director, GCP Compliance to join their team in South San Francisco, CA. The role involves providing GCP Compliance direction for clinical programs and ensuring the highest standards of quality and compliance.
About the Role
As the Director of GCP Compliance, you will lead Inspection Readiness (IR) strategies, collaborate with QA on compliance risk mitigation, and oversee issue management across clinical programs. You will also drive the development of compliance metrics and champion a culture of quality within the organization. Additionally, you will lead GCP training initiatives and support the evolution of Clinical Study Management processes.
About You
Required:
- Advanced degree in Life Sciences, Pharmacy, or related field.
- 10+ years of experience in GCP quality/compliance, including 3+ years in a leadership role.
- Deep knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
- Proven success in supporting or leading inspection readiness.
Preferred:
- Experience in the biotech or pharmaceutical industry, ideally in late-stage clinical development.
- Strong communication skills and ability to build trust across teams.
- Ability to navigate complex regulatory and organizational environments.
Benefits
- 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 snacks and drinks.
- Generous stock option grants and an annual bonus program.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
South San Francisco, CA