Clinical Quality Operations Lead – GCP & Inspections

Eikon Therapeutics; Millbrae (CA); Hybrid; USD 143,000 - 173,000; Full time

Benefits offered by this job

401k plan with company matching

Medical, dental and vision insurance

Mental health benefits

Paid time off

Life/AD&D insurance

Parental leave

Lunch program on-site

Job summary

Eikon Therapeutics seeks a Clinical Quality Operations Manager to lead quality-by-design across clinical trials and ensure inspection readiness. The role partners with CQA and cross-functional teams to implement risk-based quality plans, CtQs, and CPTA governance throughout the study lifecycle.

The onsite requirement is at least three days per week in Millbrae, CA or Jersey City, NJ, focusing on process optimization, data-driven oversight of vendors/CROs, and timely, compliant clinical

Qualifications

• Minimum 6+ years of related experience with a Bachelor's degree, or 4+ years with a post graduate degree.
• Strong knowledge of GCP, ICH E6(R3) guidelines and relevant regulations.
• Experience with CAPA management and translating findings into improvements.
• Experience with risk management tools and quality planning in clinical development.
• Ability to work cross-functionally in a matrixed environment.
• Strong communication and leadership skills; experience with document management systems is a plus.

Responsibilities

• Ensure consistent execution of quality-by-design across clinical trials and review quality plans.
• Lead CAPA implementation and coordinate remediation with study teams.
• Collaborate with CQA and study teams to maintain inspection readiness and risk-based oversight.
• Analyze trial data to identify signals and drive process improvements.
• Oversee vendor/CRO oversight plans and escalate risks as needed.
• Standardize Clinical Quality Operations procedures, tools, and templates.

Skills

GCP knowledge

CAPA management

Risk management

Cross-functional collaboration

Quality by Design

Regulatory knowledge

Veeva knowledge

Education

Bachelor's degree

Postgraduate degree

Tools

Veeva

Job description

Eikon Therapeutics seeks a Clinical Quality Operations Manager to lead quality-by-design across clinical trials and ensure inspection readiness. The role partners with CQA and cross-functional teams to implement risk-based quality plans, CtQs, and CPTA governance throughout the study lifecycle.

The onsite requirement is at least three days per week in Millbrae, CA or Jersey City, NJ, focusing on process optimization, data-driven oversight of vendors/CROs, and timely, compliant clinical