[Hiring] Senior GCP QA Manager @ICON plc

Role Description

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.

Qualifications

• 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.

Benefits

• 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, 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.