Third Party Quality Lead
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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.
What You Will Do:
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
Your Profile:
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
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
