Clinical Quality Operations Lead

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

Benefits offered by this job

401k plan with company matching

Medical, dental and vision insurance

Mental health and wellness benefits

Weeklong summer and winter shutdowns

Generous paid time off and holidays

Life/AD&D insurance and optional life/

Enhanced parental leave

Job summary

Eikon Therapeutics seeks a Clinical Quality Operations Manager to oversee operational quality management and inspection readiness across clinical programs. You will embed QbD principles, lead risk assessments, and maintain study-specific quality plans through trial lifecycles, collaborating with CQA and cross-functional teams.

The role requires on-site presence at least 3 days/week in Millbrae, CA or Jersey City, NJ to support efficient study delivery and future team growth.

Qualifications

• Minimum of 6+ years of related experience with a Bachelor's degree; or 4+ years of experience 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, preventive action development, translating CAPA findings into operational changes and tracking commitments to completion.
• Experience with risk management tools and quality planning in clinical development, including Quality by Design and risk-based approaches.
• Demonstrated ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams in a matrixed environment.
• Strong oral and written communication skills in an international environment with the ability to influence at all levels.

Responsibilities

• Ensures consistent execution of ‘quality by design’ principles in assigned clinical trials. Reviews Risk Assessment and Categorization Tools (RACTs), quality plans, and study-specific procedures with Study Management Teams to confirm accuracy, compliance with Sponsor requirements, and inspection-readiness.
• Facilitates review of CtQs, quality plans and risk mitigation approaches to identify inconsistencies, emerging signals, and trends and to provide relevant feedback to the Head of Clinical Study Management and Director of Process Management for Clinical R&D, as appropriate.
• Works with Clinical R&D peers to analyze data across Eikon’s clinical trials to identify signals and trends and translate findings into actionable process improvement strategies.
• In partnership with the Director of Process Management for Clinical R&D, the Head of Clinical Data Analytics and Reporting and the Head of Clinical Study Management, builds proficiency in leveraging technology and data to recognize and respond to new and emerging risks across assigned clinical programs, including how GCP applies to digital data management and novel trial technology.
• Partners with cross-functional study teams to ensure vendor and CRO performance is documented in vendor and CRO oversight plans and monitored against quality expectations, escalating compliance, or inspection-readiness risks to Clinical R&D functional area Heads, as necessary.
• Builds and enables effective working relationships with key stakeholders to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with Clinical Quality Assurance (CQA) and acting as the link between Clinical R&D functional areas, clinical study teams, enterprise business functions, and regional study management.
• Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates to ensure consistency and seamless progression throughout the study lifecycle.

Skills

GCP knowledge

Quality by Design

CAPA management

Risk management

Cross-functional collaboration

Regulatory inspection readiness

Leadership

Education

Bachelor's degree in a related field

Tools

Veeva or similar quality management system

Job description

Eikon Therapeutics seeks a Clinical Quality Operations Manager to oversee operational quality management and inspection readiness across clinical programs. You will embed QbD principles, lead risk assessments, and maintain study-specific quality plans through trial lifecycles, collaborating with CQA and cross-functional teams.

The role requires on-site presence at least 3 days/week in Millbrae, CA or Jersey City, NJ to support efficient study delivery and future team growth.