đĄď¸ Ensure Excellence in Clinical Research Quality & Compliance
Join ICON plc as a Clinical Quality Compliance Specialist and become a guardian of quality in clinical research. In this vital role, you'll ensure adherence to the highest standards of regulatory compliance while contributing to the development of innovative treatments that improve patient lives worldwide.
đŻ Your Impact: Key Responsibilities
Quality Management Systems
- Assist in developing and implementing quality management systems and processes
- Ensure compliance with regulatory requirements and industry standards
- Support maintenance of company policies and quality procedures
- Conduct quality reviews of clinical trial documentation and protocols
Audit & Inspection Support
- Participate in internal and external audits and inspections
- Support preparation, documentation, and response activities
- Assist in addressing audit findings and observations
- Maintain audit readiness across clinical operations
Quality Assurance & Continuous Improvement
- Conduct quality reviews to identify areas for improvement
- Collaborate with cross-functional teams on corrective and preventive actions
- Drive continuous improvement initiatives
- Monitor quality metrics and performance indicators
Compliance Guidance & Training
- Provide support and guidance on quality compliance matters
- Promote awareness of ICH-GCP guidelines and quality standards
- Share best practices across the organization
- Support quality training and education initiatives
â Your Profile: Qualifications & Experience
Essential Requirements
- Bachelor's degree or higher in Scientific or Healthcare-related field
- Experience in clinical quality assurance or compliance
- Background in pharmaceutical, biotechnology, or CRO industry
- Knowledge of FDA/EMA regulations and ICH-GCP guidelines
Technical Competencies
- Understanding of ISO standards and quality management systems
- Experience with audit preparation and response activities
- Knowledge of clinical trial documentation requirements
- Familiarity with quality review processes and methodologies
Professional Attributes
- Strong attention to detail and analytical skills
- Excellent communication and organizational abilities
- Effective problem-solving and decision-making skills
- Ability to work collaboratively in team environments
- Commitment to quality and continuous improvement
đŤ Why Join ICON?
Career Development
- Specialized role in clinical quality and compliance
- Exposure to global regulatory requirements and standards
- Opportunities for professional growth and certification
- Mentorship from quality assurance experts
Strategic Impact
- Ensure quality and compliance in groundbreaking clinical research
- Contribute to patient safety and data integrity
- Work with diverse therapeutic areas and study phases
- Influence quality culture across the organization
Comprehensive Benefits
- Competitive compensation package
- Flexible work arrangements
- Comprehensive health and wellness programs
- Global employee assistance program
- Professional development support
⨠Ready to Champion Quality in Clinical Research?
If you're a quality professional with clinical research experience and a passion for ensuring regulatory compliance, we encourage you to apply. Join us in our mission to maintain the highest standards of quality in clinical development.
Apply Now & Protect Clinical Research Excellence
