Senior Auditor, Quality Assurance - Quality & Compliance QI/CAPA team
- Sofia, Warsaw, Johannesburg
- Quality Assurance
- ICON Full Service & Corporate Support
- Hybrid: Office/Remote
Talent Acquisition Business Partner
- Full Service Division
About the role
Senior Auditor, Quality Assurance - Home or Office - South Africa, Poland and Bulgaria
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.
The Senior Auditor within the ICON Quality & Compliance QI/CAPA team
will manage complex Quality Issues to include supporting Root Cause Analysis, Impact Assessment and appropriate Corrective Action and Preventive Action (CAPA) Plans. The incumbent will be responding to audit findings and support audit responses to assess compliance with corporate policies, industry standards, and applicable regulations.
Responsibilities and Qualifications:
Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:
• Manage Quality Issues.
• Lead Quality Issue Investigations.
• Supports Operations in Root Cause Analysis and CAPA Plan preparation.
• Support Effectiveness Check development and outcomes.
• Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits.
• Assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
• Support business development activities and Q&C initiatives as needed.
• Read, write and speak fluent English.
What you will have:
• 6+ years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
• Advanced knowledge of GCP (Good Clinical Practice).
• Excellent organizational skills.
• Knowledge of internal auditing standards.
• Must possess a technical knowledge that is applicable to clinical drug development.
• An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
• Experience in investigator site, vendor, and process audits.
• Open to occasional travel, if required
• Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
• Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
• Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
• Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision
#LI-MK2
#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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Teaser label
Career ProgressionContent type
BlogsPublish 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
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Teaser label
Inside ICONContent type
BlogsPublish date
11/24/2022
Summary
Life sciences are undeniably an exciting area to start and pursue a career in. In fact, the global life sciences space is predicted to be worth a massive $2 trillion in gross value by 2023. Contra
Similar jobs at ICON
Salary
Location
South Africa, Johannesburg
Department
Full Service - Quality Assurance
Location
Sofia
Warsaw
Johannesburg
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Quality Assurance
Job Type
Permanent
Description
The Q&C Manager role will be responsible for overseeing ICONs client site audit process, including line management of the external site audit team. Roles and responsibilities will include, but not be
Reference
JR125251
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
United Kingdom
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
Job Type
Permanent
Description
As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114865
Expiry date
01/01/0001
Author
Rajvir SamraAuthor
Rajvir SamraSalary
Location
Mexico, Mexico City
Department
Full Service - Quality Assurance
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Quality Assurance
Job Type
Permanent
Description
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 an
Reference
JR125536
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Europe
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Any EMEA Location
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
Job Type
Permanent
Description
Senior Project Manager - Clinical Quality Assurance As a Senior Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intel
Reference
2024-114386
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick HaleSalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
Job Type
Permanent
Description
As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-114002
Expiry date
01/01/0001
Author
Jonathan HolmesAuthor
Jonathan HolmesSalary
Location
Durham
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Durham
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Quality Assurance
Job Type
Permanent
Description
This position is accountable for the User Acceptance Testing (UAT) process for IRT systems. Through UAT, you will be key to the clinical trial process by are ensuring quality and proper functionality
Reference
2024-114735
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie Pruitt