Senior Auditor, Quality Assurance

ICON Plc; México; A distancia; MXN 1,117,000 - 1,491,000; Jornada completa

Descripción de la vacante

A leading healthcare organization is seeking a Senior GCP Auditor, Quality Assurance in Mexico. This role involves guiding audits of clinical trials, ensuring compliance with regulatory standards, and providing expert guidance on quality assurance. Candidates should have a Bachelor's degree in Life Sciences or Pharmacy, with a minimum of 3 years of experience in quality assurance or auditing. Join us to drive innovation and excellence in clinical development.

Servicios

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Flexible optional benefits

Formación

• Minimum of 3 years of experience in quality assurance or auditing.
• Proven experience with GCP’s, site audits, and clinical quality oversight.
• Strong understanding of regulatory requirements in clinical research.

Responsabilidades

• Guiding and conducting comprehensive audits of clinical trial processes.
• Contributing to inspection readiness and participating in health authority inspections.
• Providing expert guidance and practical recommendations regarding GCP best practices.

Conocimientos

Analytical mindset

Effective communication

Attention to detail

Educación

Bachelor’s degree in Life Sciences or Pharmacy

Descripción del empleo

Senior GCP Auditor, Quality Assurance - Mexico (Home-Based)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Auditor, Quality Assurance to join our diverse and dynamic team. As a Senior Auditor, Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

What you will be doing

• Guiding and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
  
• Contributing to inspection readiness and participating in health authority inspections as needed.
  
• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
  
• Providing expert guidance and practical recommendations to stakeholders regarding GCP and quality assurance best practices.
  
• Identifying areas for improvement and contributing to the continuous enhancement of QA programs and initiatives.
  

Your profile

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field, or equivalent relevant experience.
  
• Minimum of 3 years of experience in quality assurance, auditing, or inspections within the pharmaceutical, biotechnology, or CRO industry.
  
• Proven experience with GCP’s, site audits, and clinical quality oversight.
  
• Strong understanding of regulatory requirements and quality systems related to clinical research.
  
• Analytical mindset with excellent problem-solving abilities and attention to detail.
  
• Effective communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
  
• Advanced English proficiency - fluent in reading, writing, and speaking.
  

#LI-DT2

#LI-Remote

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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