Senior Clinical Quality Operations Lead

Eikon Therapeutics; Jersey City (NJ); On-site; USD 157,000 - 189,000; Full time

Benefits offered by this job

401k plan with company matching

Medical, dental and vision insurance (

Mental health benefits

Paid time off & holidays

Life/AD&D Insurance

Parental leave

On-site lunch program

Job summary

Eikon Therapeutics in Jersey City, NJ, is seeking a Senior Clinical Quality Operations Manager (Sr. CQOM) to lead quality operations across clinical development programs, embedding QBD and risk-based quality plans, and ensuring study teams maintain inspection readiness.

This onsite role reports to the Director of Process Management for Clinical R&D and partners with CQA to drive disciplined execution. The ideal candidate has deep GCP expertise, 8+ years of clinical quality experience, strong

Qualifications

• GCP/ICH E6(R3) knowledge and other regulations.
• CAPA management with root-cause analysis and action tracking.
• Risk-based quality planning in clinical development.
• Ability to work cross-functionally with study teams and QA.
• Strong written and verbal communication in an international setting.
• Leadership, teamwork, and conflict resolution skills.
• Analytical mindset with ability to translate findings into actions.
• Experience with Veeva or similar quality management systems is a plus.

Responsibilities

• Ensure quality by design principles in trials and review RA/CT tools and plans.
• Lead TA-level reviews of CtQs and risk mitigation, providing feedback to leadership.
• Analyze data across trials to identify signals and drive improvements.
• Collaborate with leadership to leverage data and technology for risk management.
• Oversee vendor/CRO performance and plan oversight with stakeholders.
• Build strong relationships and ensure role clarity across R&D and QA.
• Standardize QO procedures, tools, and templates across study lifecycles.

Skills

GCP knowledge

CAPA management

Risk management

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree

Postgraduate degree

Tools

Veeva

Job description

Eikon Therapeutics in Jersey City, NJ, is seeking a Senior Clinical Quality Operations Manager (Sr. CQOM) to lead quality operations across clinical development programs, embedding QBD and risk-based quality plans, and ensuring study teams maintain inspection readiness.

This onsite role reports to the Director of Process Management for Clinical R&D and partners with CQA to drive disciplined execution. The ideal candidate has deep GCP expertise, 8+ years of clinical quality experience, strong