Clinical Quality Operations Manager - Remote

Overview

Employer Industry: Pharmaceutical Research and Development

• Salary up to $
• Eligible for annual bonus and long-term incentives
• Comprehensive benefits package including medical, dental, vision, and retirement options
• Opportunity for career advancement in a leading pharmaceutical company
• Hybrid work model offering flexibility with three days on-site and two days remote
• Engage in impactful work that ensures quality in clinical trials and regulatory compliance

• Oversee the strategic implementation of 'quality by design' principles in assigned clinical trials
• Develop risk assessment tools and quality plans in collaboration with clinical trial teams
• Facilitate responses to audit and inspection observations and implement process improvements
• Maintain current knowledge of regulatory inspection requirements and lead GCP inspections
• Ensure comprehensive oversight of activities delegated to third parties and develop quality agreements

• Minimum of 6 years in clinical research, with at least 2 years in clinical quality systems and regulatory inspections
• Profound knowledge of clinical development programs, clinical trial processes, and quality management systems
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
• Proven experience in delivering effective CAPA management solutions
• Ability to analyze, interpret, and solve complex problems in an international environment

• Additional formal education in quality management or business management
• Experience with risk management tools and processes within clinical quality frameworks
• Strong project management and organizational skills
• Proven ability to lead cross-functional teams and manage others effectively
• Exceptional oral and written communication skills in a diverse environment

#Pharmaceutical Research #Clinical Quality #Regulatory Compliance #Career Opportunity #Hybrid Work Model

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