Senior Auditor, Quality Assurance

ICON Clinical Research; Ciudad de México; A distancia; USD 40,000 - 60,000; Jornada completa

Descripción de la vacante

A global healthcare organization is seeking a Senior Auditor, Quality Assurance to ensure compliance of clinical trials, interpret regulatory requirements, and contribute to innovative treatments. This remote role requires a Bachelor's degree in a science-related field and offers competitive salary and extensive benefits for employee well-being and work-life balance.

Servicios

Health insurance options

Competitive retirement planning

Global Employee Assistance Programme

Flexible optional benefits

Formación

• Minimum of 5 years of experience in quality assurance within the pharmaceutical industry.
• At least 2 years in a leadership or senior role.
• In-depth knowledge of regulatory requirements governing clinical trials.

Responsabilidades

• Conduct comprehensive audits of clinical trial processes.
• Collaborate with teams to improve quality assurance processes.
• Develop and implement audit plans to assess quality management systems.
• Provide guidance on quality assurance best practices.

Conocimientos

Analytical skills

Problem-solving skills

Communication skills

Interpersonal skills

Educación

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Descripción del empleo

Senior Auditor, Quality Assurance - Mexico - Remote (HomeBased)

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 inNvative 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.

• Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.

• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.

• Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.

• Contributing to the continuous improvement of quality assurance programs and initiatives.

Your profile

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechNlogy, or CRO industry, with at least 2 years in a leadership or senior role.

• In-depth kNwledge 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 address complex quality issues.

• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)

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 (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply