Director, Clinical Quality Assurance - Contractor

What this role involves

Alumis is hiring a Director of Clinical Quality Assurance (contractor) to ensure quality throughout clinical programs. The role requires 10+ years of ICH-GCP/GVP QA experience and expertise in FDA regulations. Responsibilities include auditing, compliance oversight, and supporting health authority inspections.

Skills this posting asks for

• ich-gcp
• gvp
• auditing
• fda regulations
• ich guidance
• drug life cycle management
• clinical operations
• clinical development
• clinical supply chain
• data management
• pharmacovigilance
• medical affairs
• regulatory
• legal
• root cause analysis
• quality assurance
• clinical qa
• small molecule products
• solid oral dosage forms

Requirements

• 10 years of experience
• Level: director

From the employer’s posting

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 fundamental…