Clinical Quality Operations, Oncology III

Responsibilities

• Oversight of implementing `quality by design` in clinical trials across assigned therapeutic areas.
• Development of Risk Assessment and Quality Plans in collaboration with Clinical Trial Teams.
• Quarterly reviews of quality plans to detect trends and provide feedback to stakeholders.
• Facilitation of responses to audits and inspections, analyzing data for process improvement.
• Maintenance of regulatory inspection readiness knowledge and management of preparation activities for various authorities.

Qualifications

• Bachelor's or Master's degree in a relevant healthcare area; advanced study in quality management preferred.
• Minimum of 6 years in clinical research; 2 years in managing clinical quality systems and regulatory inspections.
• Deep familiarity with clinical development programs and quality management systems.
• Expertise in Good Clinical Practice (GCP)/ICH and regulatory requirements globally.
• History of effective CAPA management solutions and experience with risk management tools.

Benefits

• Comprehensive medical, dental, and vision insurance for employee and family.
• Retirement benefits, including a 401(k) plan.
• Paid holidays, vacation, compassionate leave, and sick days available.
• Eligibility for annual bonuses and long-term incentives.