Clinical Quality Compliance Lead
- United States
- Quality Assurance
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Job Summary
- Under the leadership of the Operations Quality Lead, supports or may lead inspection readiness initiatives
- Creates process and tools to achieve inspection readiness within Development Operations
- With DOQ leadership, helps to facilitate the growth of opportunities for collaboration with QA, collaborating with the Operations Quality Lead and the Operations Quality Manager
General Responsibilities
- Develop and maintain guidance and process to facilitate DOQ support of Study Teams
- Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis
- Provide training or awareness for new or established processes or guidance provided by DOQ
- Collaborate in developing and presenting DOQ content for distribution within the organization
- Author relevant content for the DOQ SharePoint site
- Act as lead on specified DOQ workstreams or assigned DOQ initiatives
- In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests that are sent to DOQ
- Consult, develop, or identify opportunities for continuous improvement projects
- Develop, review, and analyze KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality within Development Operations
- Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials
- Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus
- Develop matrix relationships to involve process experts and conduct improvement activities
- Collaborate with DOQ Leadership to ensure integration, alignment, and consistent messaging across the organization
- Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do
You are:
- Bachelor’s degree or equivalent with a strong emphasis on science or quality management
- Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent
- Minimum of 3 years’ experience in quality role
- Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience
- Ability to travel
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, 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 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.
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
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
Our PeopleContent type
BlogsPublish date
02/28/2023
Summary
John Bailey, one of ICON's Veteran Leadership Transition Program Alumni shares his path from serving in the armed forces to joining the clinical research industry. ICON's Veteran Leadership Transit
by
John Bailey
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
Poland, Warsaw
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 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 a
Reference
JR125065
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
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