Clinical Quality Operations Lead

Regulatory Jobs; Millbrae (CA); On-site; USD 143,000 - 173,000; Full time

Benefits offered by this job

401k with match

Medical/Dental/Vision

Mental health benefits

Holiday shutdowns

Generous PTO

Life/AD&D Insurance

Parental leave

Lunch on-site

Job summary

Eikon Therapeutics seeks a Clinical Quality Operations Manager (CQOM) to lead quality-by-design and risk-based quality plans across clinical trials. You’ll collaborate with CQA, Study Management, and R&D to ensure inspection readiness and study-level excellence.

The role requires hands-on QA leadership, CAPA management, and data-driven risk assessment, with onsite presence at Millbrae, CA or Jersey City, NJ offices at least 3 days/week.

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.
• Experience with CAPA management, including root cause analysis and corrective actions.
• Experience with risk-based quality planning in clinical development (QbD).
• Demonstrated ability to work cross-functionally in a matrixed clinical environment.
• Excellent written and verbal communication in international settings.
• Experience with Veeva or similar document/quality management systems is a plus.

Responsibilities

• Ensures consistent execution of quality by design in clinical trials and reviews RA/CT tools.
• Facilitates review of CtQs, quality plans, and risk mitigation to identify inconsistencies and trends.
• Works with R&D peers to analyze data and translate findings into process improvements.
• Leads data-driven risk management and analytics across trials to identify new risks.
• Partners with cross-functional teams to monitor vendor/CRO performance and oversight plans.
• Builds strong relationships with stakeholders and aligns Clinical R&D with QA and enterprise functions.
• Contributes to standardizing CQO procedures, tools, and templates across study lifecycles.

Skills

GCP Knowledge

ICH E6(R3)

CAPA Management

Quality by Design

Risk Management

Cross-functional Collaboration

Veeva / QMS

Education

Bachelor’s degree

Advanced degree preferred

Tools

Veeva

Job description

Eikon Therapeutics seeks a Clinical Quality Operations Manager (CQOM) to lead quality-by-design and risk-based quality plans across clinical trials. You’ll collaborate with CQA, Study Management, and R&D to ensure inspection readiness and study-level excellence.

The role requires hands-on QA leadership, CAPA management, and data-driven risk assessment, with onsite presence at Millbrae, CA or Jersey City, NJ offices at least 3 days/week.