Clinical Quality Operations Manager

The role

The Clinical Quality Operations Manager executes operational quality management and inspection readiness activities across clinical programs. This role embeds quality-by-design principles, risk-based quality plans, and vendor oversight into clinical trials.

What you will do

• Ensures consistent execution of quality by design principles in assigned clinical trials.
• Reviews Risk Assessment and Categorization Tools, quality plans, and study-specific procedures.
• Facilitates review of CtQs, quality plans and risk mitigation approaches.
• Analyzes data across clinical trials to identify signals and trends for process improvement.
• Partners with study teams to ensure vendor and CRO performance is monitored.
• Builds working relationships with key stakeholders and Clinical Quality Assurance.
• Contributes to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Maintains knowledge of global GCP inspection practices.
• Supports CQA in developing and maintaining GCP inspection procedures and guidelines.
• Leads CAPA implementation for CQA-sponsored internal audits.

Required 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.
• Strong teamwork and leadership skills, including conflict resolution expertise.
• Ability to analyze, interpret and solve complex problems.
• Ability to think strategically and objectively while applying creativity and innovation.
• Ability to synthesize findings and deliver lessons learned.

Nice to have

• Lean six sigma
• PMP
• Experience with Veeva or similar document and quality management systems

Benefits

• 401k plan with company matching
• Medical (premiums covered by Eikon at 95%)
• Dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%)
• Optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

About the company

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.