Asset Quality Lead

ICON plcBlue Bell, SD
Remote

About The Position

Asset Quality Lead ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Asset Quality Lead at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
  • Minimum of 10 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with significant experience in a leadership role.
  • Extensive 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 complex quality issues.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
  • Willingness to travel as required (approximately 25%)
  • Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

  • Advanced degree preferred.

Responsibilities

  • Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.
  • Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
  • Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
  • Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
  • Contributing to the continuous improvement of quality management systems and documentation.

Benefits

  • 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
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