Principal Auditor, Client Relationships QA

Icon Plc•Blue Bell, PA

52d•Remote

About The Position

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. We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team in Client Relationship Quality Assurance (CRQA). As a Principal Auditor CRQA at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of Innovative treatments and therapies for the sponsor companies we support while establishing, building and maintaining successful relationships with our sponsor companies' counterparts.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechNlogy, or CRO industry, with at least 3 years in a leadership role.
In-depth kNwledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

Responsibilities

Relationship Management with internal business partners within ICON and with Sponsor QA counterparts
Client communications support
Client audit support
Client inspections support
Governance structure development and review of quality data (audits, quality issues, inspections) with sponsor quality counterparts, operations within ICON and at the sponsors
ICON Quality &Compliance representation at sponsor and internal partnership meetings
Liaise with ICON Q&C functions who carry out the management of quality activities and data (audits, quality issues and inspections)
Reviewing quality data managed by ICON Q&C functional teams and tracked in ICON's Audit Compliance Management System (ACMS), Trackwise Digital, the CRQA Principal Auditor will be responsible for:
Quality Risk Mitigation
Quality Issue Escalation & Root Cause Analysis
Data Analysis & Reporting (Trending, interpretation, analysis)
Quality Improvements
QA Consultancy Support
GxP Guidance
Inspection Readiness
Regulation/Requirements Interpretation
Contractual Agreements

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, 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.

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