Senior Auditor, Quality Assurance

Posted Yesterday
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Mexico City, Cuauhtémoc, Mexico City, MEX
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Lead and conduct comprehensive audits of clinical trial processes, systems, and documentation to ensure GCP and regulatory compliance. Develop and implement audit plans, support inspection readiness and health authority inspections, provide expert guidance and practical recommendations, identify improvement opportunities, and contribute to continuous enhancement of QA programs.
Summary Generated by Built In
Senior Auditor, Quality Assurance

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.


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

  • Leading 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 5 years of experience in quality assurance, auditing, or inspections within the pharmaceutical, biotechnology, or CRO industry.

  • Proven experience with GCP’s (Good Clinical Practices), site audits, and clinical quality oversight. (NOT other GxP’s)

  • 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


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

Skills Required

  • Bachelor's degree in Life Sciences, Pharmacy, or related field, or equivalent relevant experience.
  • Minimum of 5 years experience in quality assurance, auditing, or inspections within pharmaceutical, biotechnology, or CRO industry.
  • Proven experience with GCPs (Good Clinical Practices), 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 ability to work collaboratively across cross-functional teams.
  • Advanced English proficiency — fluent in reading, writing, and speaking.

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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