Senior Clinical Quality Operations & Inspection Lead

Eikon Therapeutics; Millbrae (CA); On-site; USD 157,000 - 189,000; Full time

Benefits offered by this job

401k with match

Medical/Dental/Vision insurance

Mental health benefits

Paid time off and holidays

Life/AD&D insurance

Enhanced parental leave

Lunch on-site

Job summary

Eikon Therapeutics is seeking a Senior Clinical Quality Operations Manager to lead quality-by-design across clinical trials, drive risk-based quality plans, and oversee vendor oversight in collaboration with CQA and study teams. The role emphasizes GCP mastery, CAPA leadership, and global inspection readiness.

The role requires 8+ years of related experience with a Bachelor's degree (or 6+ with a postgraduate degree); strong knowledge of GCP/ICH guidelines and risk-based approaches, plus

Qualifications

• Minimum 8+ years of related experience with a Bachelor’s degree; or 6+ years with a post graduate degree.
• In-depth knowledge of GCP, ICH E6(R3) guidelines and other relevant regulations.
• Demonstrated experience with CAPA management including root-cause analysis and action tracking.
• Experience with risk management tools and quality planning in clinical development.
• Excellent cross-functional collaboration and communication in a matrixed environment.

Responsibilities

• Ensures consistent execution of quality-by-design in assigned clinical trials; reviews RA(D) tools and quality plans for inspection-readiness.
• Facilitates review of CtQs, quality plans, and risk mitigation with study teams.
• Analyzes data across trials to identify signals and translate findings into process improvements.
• Leads CAPA implementation and remediation with internal audits and external inspections.
• Partners with CQA to ensure inspection readiness across Clinical R&D functions.
• Develops standardized Clinical Quality Operations procedures, tools, and templates.

Skills

GCP knowledge

Quality operations leadership

Cross-functional collaboration

Regulatory inspections

CAPA management

Risk management

Communication skills

Education

Bachelor’s degree

Postgraduate degree

Tools

Veeva

Quality management systems

Job description

Eikon Therapeutics is seeking a Senior Clinical Quality Operations Manager to lead quality-by-design across clinical trials, drive risk-based quality plans, and oversee vendor oversight in collaboration with CQA and study teams. The role emphasizes GCP mastery, CAPA leadership, and global inspection readiness.

The role requires 8+ years of related experience with a Bachelor's degree (or 6+ with a postgraduate degree); strong knowledge of GCP/ICH guidelines and risk-based approaches, plus