ICON plc

Clinical Quality Compliance Lead

ICON plc$110K — $130K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in a relevant scientific discipline or healthcare field.
  • Experience in clinical quality assurance or compliance in pharmaceutical, biotechnology, or CRO industries.
  • Expertise in regulatory requirements like FDA/EMA regulations and ICH-GCP guidelines.
  • Strong leadership and project management skills to prioritize tasks effectively.
  • Excellent communication and problem-solving skills for stakeholder collaboration.
  • Willingness to travel approximately 65% of the time.

Responsibilities

  • Develop and implement quality management systems to ensure compliance with regulations and standards.
  • Lead audits and inspections, managing planning, execution, and follow-up to address findings.
  • Conduct quality reviews of clinical trial documentation and protocols, identifying improvements.
  • Provide leadership, training, and performance management to the clinical quality compliance team.
  • Collaborate with cross-functional teams to assess risks and develop mitigation strategies.

Benefits

  • Competitive base salary and performance-related incentives.
  • Health and wellbeing programmes, including medical, dental, and vision coverage.
  • Retirement and pension plans.
  • Life assurance and disability coverage.
  • Employee assistance programmes and wellbeing resources.
  • Learning and development opportunities through structured training.
Full Job Description
Clinical Quality Compliance Lead

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 to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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