Clinical QA manager

 Posted 2 hours ago
  
 Poland
  
5-10 years experience
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AI Summary

The role is responsible for ensuring clinical trial compliance at country and site levels using a risk-based approach. Key duties include conducting quality assessments, implementing QA strategies, and collaborating with stakeholders to safeguard patient safety and data integrity.
Clinical quality compliance Manager

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 QA Manager at ICON, you will be  is responsible for ensuring robust oversight of clinical trial compliance at the country and site level. This role applies a risk-based approach to proactively identify, evaluate,
and manage compliance risks, ensuring adherence to Good Clinical Practice (GCP), company procedures, and regulatory requirements. The role partners closely with country, regional and global stakeholders to safeguard
patient safety, data integrity, and inspection readiness.

What You Will Do:

Your focus will be on coordinating clinical quality assurance and compliance delivery, resolving issues, and developing team capability.

Key responsibilities include:

  • 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.

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 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.


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

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