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ICON plc

Quality Assurance Manager

ICON plc

. Ensure the quality and compliance of clinical trials, interpret regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Posted 9/21/2026full-timeRemote • Pennsylvania • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in quality assurance and compliance within clinical trials, with a strong understanding of regulatory requirements and guidelines. Proven ability to develop quality management systems and collaborate effectively with cross-functional teams to resolve quality issues.

Highest-signal resume keywords
Quality AssuranceRegulatory ComplianceClinical TrialsAnalytical SkillsCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Quality Management SystemsQuality AssessmentsAuditsRegulatory RequirementsCorrective ActionsQuality Assurance StrategiesProblem-Solving
Soft Skills
Interpersonal SkillsCollaboration
Industry Keywords
PharmaceuticalBiotechnologyCROICH-GCPFDA Regulations

About the role

Key responsibilities & impact
  • Ensure the quality and compliance of clinical trials, interpret regulatory requirements, and contribute to the advancement of innovative treatments and therapies.
  • Develop and implement quality assurance strategies and processes to support clinical trial activities.
  • Conduct quality assessments and audits to ensure compliance with regulatory standards and guidelines.
  • Collaborate with project teams to identify and address quality issues and implement corrective actions as needed.
  • Provide guidance and support to staff regarding quality assurance policies, procedures, and best practices.
  • Contribute to the development and maintenance of quality management systems and documentation.
  • Coordinate quality assurance and compliance delivery, resolve issues, and develop team capability.

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%)
  • Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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