Associate Director, Clinical Quality Assurance

Scorpion Therapeutics; California (MO); On-site; USD 186,000 - 233,000; Full time

Benefits offered by this job

Comprehensive total rewards

Onsite work in Redwood City

Job summary

Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance to lead GCP compliance and quality oversight of oncology trials, focusing on RAS-targeted therapies. You will drive quality systems, collaborate across Clinical Operations and Development, and ensure readiness for inspections.

The role requires a strong background in GCP, FDA regulations, and CAPA processes, with excellent communication and stakeholder management skills.

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• 10+ years of GCP quality experience in pharma/biotech.
• 8+ years in audit management, inspection readiness and CAPA processes.
• Deep knowledge of ICH GCP, FDA regulations, and drug development standards.
• Strong communication, problem-solving, and stakeholder management skills.
• Proficiency in Microsoft Office.

Responsibilities

• Develop and maintain Quality Systems.
• Collaborate with Clinical Operations and Development teams for GCP compliance.
• Participate in clinical study teams.
• Review trial documents for regulatory adherence.
• Support audit and inspection activities.
• Manage risk assessments, CAPAs, and quality issues.
• Ensure inspection readiness.
• Foster cross-functional relationships.

Skills

GCP Quality

Audit management

FDA regulations

ICH GCP

Stakeholder management

Communication

CAPA processes

Education

Bachelor’s degree in science/engineering

Job description

Role

Associate Director, Clinical Quality Assurance, responsible for leading GCP compliance and quality oversight of Revolution Medicines' clinical trials in oncology, focusing on RAS-targeted therapies.

Responsibilities

• develop and maintain Quality Systems;
• collaborate with Clinical Operations and Development teams for GCP compliance;
• participate in clinical study teams;
• review trial documents for regulatory adherence;
• support audit and inspection activities;
• manage risk assessments, CAPAs, and quality issues;
• ensure inspection readiness;
• foster cross-functional relationships.

Requirements

• Bachelor’s in a scientific/technical discipline;
• 10+ years in GCP Quality within pharma/biotech;
• 8+ years in audit management, inspection readiness, deviation/CAPA processes;
• deep knowledge of ICH GCP, FDA regulations, and drug development standards;
• strong communication, problem‑solving, and stakeholder management skills;
• proficiency in Microsoft Office.

Preferred

familiarity with Computer System Validation.

Work Setup

onsite at Redwood City, CA; salary range $186K-$233K, with comprehensive total rewards.