Third Party Quality Lead

ICON plc • Blue Bell, SD

23h • Remote

About The Position

The Third Party Quality Lead (TPQL) reports to the Head of Third Party Quality and partners with stakeholders to manage third-party quality risk, issue resolution, and GCP compliance. This role acts as the primary Quality contact for key vendors supporting Clinical Development & Operations, ensuring they maintain strong quality systems and meet all applicable regulatory GCP requirements related to patient safety, data integrity, and protocol adherence. The TPQL also supports vendor oversight, engagement frameworks, and quality processes across external partnerships.

Requirements

• BS--7+ years or equivalent
• MS/MBA – 6+ years or equivalent
• Minimum of 5 years of pharmaceutical experience with solid experience in clinical trial development
• Robust knowledge in quality areas (i.e. audit, inspection, compliance, and inspection readiness fields)
• Quality related experience including working knowledge in: Quality and compliance management, QC Root Cause Analysis
• Risk identification, controls, mitigations, and actions
• Metrics development and utilization
• Audit and Inspection conduct and CAPA response process
• Ability to develop strategies using coordinated and transparent metrics to track and manage compliance
• Ability to participate in cross-line global initiatives or root cause analysis for quality related process improvement

Responsibilities

• Identify, evaluate and respond to GCP quality risks related to vendor and site engagement
• Lead quality discussions with key vendors and sites and present quality point of view at relevant oversight meetings
• Provide quality oversight reports to appropriate Pfizer management / functions
• Communicate key quality information (e.g., inspection / audit learnings) across vendors and site entities and serve as quality expert for third parties
• Validate, monitor and close out GCP-quality-related action plans
• Evaluates quality performance at an enterprise level to inform continuous improvement of quality risk management
• Informs site organization relationship owner of quality improvement considerations
• Support QMS09 BPO in the development and implementation of process updates
• Support Vendor Leads / Business Owners to ensure compliance with functional level vendor oversight requirements

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior