Senior GCP QA Manager

Senior GCP QA Manager

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.

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

The role is 100% embedded within a company that creates transformative medicines for people with serious diseases with a focus on specialty markets.

You will play a key role in making improvements to how teams perform their work, supporting positive gains on compliance and reducing procedural complexity within the Clinical Quality Assurance team.

What You Will Be Doing:

• Lead cross-functional teams to drive investigation, root cause analysis (RCA) and CAPA development for Global Clinical Operations (GCO) Quality Events (QEs).
• Author investigation summary, RCA, Impact Assessments and CAPA utilizing Veeva QMS.
• Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management.
• Perform effectiveness checks, as assigned.
• Own and facilitate GCO planned deviations.
• Identifies and solves complex technical and operational problems, leveraging the appropriate resources.
• Liaise with Vertex clinical functions and external parties including CROs and Vendors to promote high level of quality and consistency across and within programs.

Your Profile:

• A bachelor’s degree or master’s degree
• Strong end to end clinical trial execution experience.
• Must have experience in managing Quality Events directly
• Strong verbal/written communication, presentation and interpersonal skills.
• Familiarity with Veeva QMS system
• In-depth understanding of GCP, ICH guidelines, CFR and ROW equivalents
• Excellent verbal and written communication skills and presentation skills: ability to interact well with various team members and provide value added support to project 
• Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment 
• Experience managing clinical quality activities and in-depth knowledge of clinical operations. 

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, 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, 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