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Manager, Quality Assurance – EU Q&C Audit Defense Team
ICON plcQuality Assurance Manager leading client audits for ICON, a global healthcare organization, ensuring compliance and quality assurance in clinical trials. Developing strategies and conducting assessments in collaboration with various project teams.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
quality assurancequality management systemsregulatory compliancequality assessmentsauditscorrective actionsclinical trial activitiesdocumentation
Soft Skills
analytical skillsproblem-solving skillscommunication skillsinterpersonal skillscollaboration skills
Certifications & Qualifications
Bachelor's degree
Industry Keywords
pharmaceutical industrybiotechnology industryCRO industryICH-GCPFDA regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Developing and implementing quality assurance strategies and processes to support clinical trial activities
- Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines
- Collaborating with project teams to identify and address quality issues and implement corrective actions as needed
- Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices
- Contributing to the development and maintenance of quality management systems and documentation
Requirements
What you’ll need- Bachelor's degree in a relevant discipline
- Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry
- Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations)
- Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders
- Willingness to travel as required (approximately 35%)
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways