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Clinical Quality Compliance Lead

ICON plc
Posted 2 days ago, valid for 19 days
Location

Blue Bell, SD, US

Salary

Competitive

Contract type

Full Time

Retirement Plan
Life Insurance
Employee Assistance

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Sonic Summary

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  • ICON is seeking a Clinical Quality Compliance Lead to oversee quality assurance and compliance in clinical trials, ensuring high standards and timelines are met.
  • Candidates should have a Bachelor's degree or higher in a relevant scientific discipline and at least 5 years of experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
  • Key responsibilities include developing quality management systems, leading audits, conducting quality reviews, and providing leadership to the compliance team.
  • A competitive salary and performance-related incentives are offered, along with comprehensive health and wellbeing benefits, retirement plans, and professional development opportunities.
  • ICON values integrity, collaboration, agility, and inclusion, and is committed to creating an accessible workplace for all employees.
Clinical Quality Compliance 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 Clinical Quality Compliance Lead at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.


What You Will Do:

You will oversee quality assurance and compliance workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

  • Develop and implement comprehensive quality management systems and processes to ensure compliance with regulatory requirements, industry standards, and company policies.
  • Lead internal and external audits and inspections, including planning, execution, and follow-up activities to address findings and ensure timely resolution.
  • Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying areas for improvement and implementing corrective actions as necessary.
  • Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management.
  • Collaborate with cross-functional teams to assess quality risks, develop risk mitigation strategies, and drive continuous improvement initiatives.

Your Profile:

You will have solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

  • Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
  • Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry.
  • Expert knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards.
  • Strong leadership and project management skills, with the ability to effectively prioritize tasks and manage resources to meet objectives.
  • Excellent communication, interpersonal, and problem-solving skills, with the ability to influence and collaborate with stakeholders at all levels of the organization.
  • Willingness to travel as required (approximately 65%)

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


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • 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

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply




Learn more about this Employer on their Career Site

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