JUMP TO CONTENT

Manager, Clinical Quality Compliance

  1. United States
2025-120783
  1. Quality Assurance
  2. ICON Strategic Solutions
  3. Home-Based

About the role

As a Manager, Clinical Quality Compliance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


What you will be doing:

  • Perform and lead audits including but not limited to: clinical investigator sites, internal GCP systems/processes, external vendors, and clinical trial documents.
  • Identify and report systematic issues and areas for improvement with the assistance of management/senior auditor, as needed.
  • Independently perform audits, including audit preparation, conduct, presentation and timely reporting of audit findings and evaluation of CAPA Plans.
  • Ensure appropriate corrective and preventative actions have been committed to by auditees.
  • Conduct post-audit meetings to present/discuss audit findings.
  • Assist in assessment of appropriate CAPA implementation.
  • Perform other tasks as assigned by line manager.
  • Contribute in the continuing development of a quality culture
  • Approximately 50% travel

 


You are:

 

  • BS/BA, or MS and a minimum of 5 or 10 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
  • Working knowledge of Good Clinical Practice (GCP) required
  • Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
  • Experience working with CROs, vendors, and relationship management preferred.
  • Prior experience managing individuals preferred.
  • Vaccine clinical trials experience is a plus.
  • Excellent auditing skills and ability to communicate significant observations to Auditees in a sound and factual manner. 
  • Ability to manage multiple projects in a fast-paced environment. 
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to work independently and within a team environment.
  • Strong communication and presentation skills, verbal and written.
  • Ability to influence and negotiate effective solutions.
  • GCLP experience
  • Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.


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 maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others



Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

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.

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
EPIC Interns
ICONs EPIC Internship Program

Teaser label

Career Progression

Content type

Blogs

Publish date

07/20/2023

Summary

Unlocking your Potential: The Benefits of ICON’s EPIC Internship Program  Internship programs have become a vital stepping stone for students and young professionals seeking to gain practic

Teaser label

Read more about ICON plc's EPIC (Entry-level Professionals in CRO (Contract Research Organization)) internship program.

Read more
View all

Similar jobs at ICON

Workday TA Transformation Analyst

Salary

Location

Bulgaria, Sofia

Department

Full Service - Corporate Support

Location

Sofia

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Human Resources

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior HR Transformation Analyst to join our diverse and dynamic team. As a Senior HR Transformation Analyst at ICON, you will be pivotal in driving HR transformation initia

Reference

JR132974

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Quality Assurance Auditor II - GMP

Salary

Location

Poland, Warsaw

Department

Full Service - Quality Assurance

Location

Sofia

Warsaw

Johannesburg

Gdansk

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

What will you be doing as Quality Assurance Auditor II?We are looking for you to join our team in the Poland or Bulgaria where you will assume responsibility for quality assurance activities to suppor

Reference

JR133134

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior Quality Assurance Specialist

Salary

Location

Spain, Barcelona

Department

Language Services

Location

Prague

Warsaw

Barcelona

Reading

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior Quality Assurance Specialist to join our dynamic team. You will play a critical role in ensuring and advancing quality across ICON’s Language Services department. Rep

Reference

JR132675

Expiry date

01/01/0001

Rowena Deswert Read more Shortlist Save this role
Quality Assurance Auditor II

Salary

Location

US, Salt Lake City (PRA)

Department

Full Service - Quality Assurance

Location

Salt Lake City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Quality Assurance Auditor II to join our diverse and dynamic team in our Early Phase Unit. As a Quality Assurance Auditor II at ICON, you will play a pivotal role in ensurin

Reference

JR132163

Expiry date

01/01/0001

Muna Nelke

Author

Muna Nelke
Muna Nelke

Author

Muna Nelke
Read more Shortlist Save this role
Senior HR Transformation Analyst

Salary

Location

India, Chennai

Department

Full Service - Corporate Support

Location

Bangalore

Chennai

Trivandrum

Bengaluru

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Human Resources

Quality Assurance

Job Type

Permanent

Description

We are currently seeking a Senior HR Transformation Analyst to join our diverse and dynamic team. As a Senior HR Transformation Analyst at ICON, you will be pivotal in driving HR transformation initia

Reference

JR132092

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior QA Auditor - Client Audit Management

Salary

Location

Bulgaria, Sofia

Department

Full Service - Quality Assurance

Location

Sofia

Warsaw

Johannesburg

Tbilisi

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Quality Assurance

Job Type

Permanent

Description

The opportunity: The Audit Defense team are seeking an individual to join them as a Senior QA Auditor position.  This is a great opportunity for someone with a clinical background to develop their car

Reference

JR131582

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above