Clinical Quality Operations Lead — Onsite 3 Days/Week

Eikon Therapeutics; Jersey City (NJ); On-site; USD 143,000 - 173,000; Full time

Benefits offered by this job

401k match

Medical/dental/vision insurance

Mental health benefits

Paid time off & holidays

Parental leave

Lunch on-site

Job summary

Eikon Therapeutics seeks a Clinical Quality Operations Manager (CQOM) to lead operational quality management across clinical programs. The role partners with the Director of Process Management for Clinical R&D and reports to drive QbD, CtQ risk assessments, and study-level quality plans in a matrixed environment.

The CQOM will ensure inspection readiness, manage CAPA programs, and collaborate with CQA and Clinical R&D teams to optimize study execution and timelines.

Qualifications

• Minimum 6+ years of related experience with a Bachelor's degree; or 4+ years with a post graduate degree.
• Strong working knowledge of GCP, ICH E6(R3) guidelines and other relevant regulations and guidelines.
• Experience with CAPA management, including root cause analysis and corrective actions.

Responsibilities

• Ensures consistent execution of quality by design in assigned clinical trials and reviews risk assessment tools and quality plans.
• Facilitates review of CtQs, quality plans and risk mitigation approaches to identify inconsistencies and trends.
• Collaborates with cross-functional teams to analyze data and translate findings into process improvements.
• Leads CAPA implementation and coordinates training for study teams on process changes.
• Supports regulatory readiness and inspection preparation with CQA.

Skills

GCP knowledge

CAPA management

Risk management

Quality by Design

Cross-functional collaboration

Veeva experience

Regulatory inspections

Education

Bachelor's degree

Tools

Veeva

Job description

Eikon Therapeutics seeks a Clinical Quality Operations Manager (CQOM) to lead operational quality management across clinical programs. The role partners with the Director of Process Management for Clinical R&D and reports to drive QbD, CtQ risk assessments, and study-level quality plans in a matrixed environment.

The CQOM will ensure inspection readiness, manage CAPA programs, and collaborate with CQA and Clinical R&D teams to optimize study execution and timelines.