Sr. Manager, Clinical Quality Assurance (CQA)
About the role
This vacancy has now expired. Please click here to view live vacancies.
- Directly manage team of 9 Auditors located in the Americas
- Effectively implement and maintain Clinical Quality Assurance procedures and processes in adherence with ICON SOPs, ICH GCP and appropriate regulations
- Ensure all necessary training is provided to auditors to improve their performance and knowledge. Provide coaching/mentoring and a benchmark of auditing competencies, as necessary.
- Effectively manage the CQA audit program including coordination of project allocation and ensuring that all necessary project assessments, audit schedules and plans are completed and cover areas of high risk. Proactively flag potential issues to regional Director/Senior Director. CQA.
- Provide expertise and leadership in Quality Compliance to the wider organization and ensure that all personnel are aware of ICON requirements for quality.
- Perform the QA review for assigned procedures and act as an author/subject matter expert on procedures when designated this responsibility.
- Effectively manage the tracking and analysis of defined CQA quality and performance metrics. Ensure CQA audits are conducted and reported according to relevant timeframes and plans and liaise with appropriate managers as necessary in order to achieve this.
- Ensure regular analysts and reporting of audit trends for presentation to operational departments and for risk assessment and audit planning purposes.
- Provide input into regional QA department budget in conjunction with the relevant Director/Senior Director and promote effective cost control.
- Keep direct line manager informed of any quality issues within the department/office which require attention.
- Manage the allocation of workload and supervision of auditors in relevant office(s).
- Monitor metrics and QA reports and addresses performance issues and trends accordingly.
- Perform required managerial tasks for staff such as performance review and setting clear goals and objectives.
- Create an environment that motivates people, acting as a mentor and sharing expertise.
- Bachelor’s Degree or local equivalent in medicine, science or equivalent degree/experience
- MSc or PhD In life science medicine, or related field would be an asset
- Minimum of 5 years active experience in a quality/regulatory compliance position, with a proven track record of success in managing quality projects and teams with broad quality assurance experience
- Minimum of 3 years directly managing a team
- In-depth knowledge and understanding of drug development and the clinical trial process
- Thorough knowledge of current regulatory and ICH GCP requirements and experience with global regulations and guidelines, required
- A satisfactory progression of auditing experience in pharmaceutical company or Clinical Research Organization (CRO)
- Medical device auditing experience a plus
- Highly developed problem solving skills and the ability to resolve difficult conflicts
- Strong people management and communication skills with the ability to Influence others and gain commitment; Demonstrated training skills, including the ability to give constructive feedback
- Cost consciousness, with good commercial awareness and customer focus
- Ability to multitask and to work efficiently and independently
- Willingness to travel approximately 35% domestic and international
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 Learn more about Our Culture at ICON
Day in the life
.png)
Teaser label
IndustryContent type
BlogsPublish date
06/06/2025
Summary
Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/29/2025
Summary
Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/22/2025
Summary
World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ
Similar jobs at ICON
Salary
Location
Brazil
Department
Clinical Monitoring
Location
Brazil
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2025-119862
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-118288
Expiry date
01/01/0001
Author
Melissa BennerAuthor
Melissa BennerSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Reference
2025-119052
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Full Service - Global Business Services
Location
New York
Blue Bell
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
We are currently seeking a Program Manager, Laboratory to join our team; Here is what you will be doing.Program Manager- Farmingdale NY or Blue Bell PA- Hybrid A Program Manager (PrgM) will have respo
Reference
JR130137
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
Reading
Department
Clinical Trial Management
Location
Reading
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
Study Delivery PM Support (for Complex Studies) – Oncology Division (UK, home-based) - Real World Evidence You will be partnering with a well-known global pharmaceutical company with a strong portfoli
Reference
2025-118776
Expiry date
01/01/0001
Author
Dominic BradyAuthor
Dominic BradySalary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Business Area
ICON Full Service & Corporate Support
Job Categories
Corporate Support
Job Type
Permanent
Description
As a Contract Analyst at ICON, you will play a crucial role in the coordination and development of contracts and change orders for newly awarded and ongoing clinical research projects. This is an exci
Reference
JR131376
Expiry date
01/01/0001
Author
Lauren PritchettAuthor
Lauren Pritchett