Third Party Quality Lead - US or Canada
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 qualityimprovement considerations
Support QMS09 BPO in the development and implementation of process updates
Support Vendor Leads / Business Owners to ensurecompliance 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 solidexperience 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
What ICON can offer you:
Our success depends on the quality of our people. Thats why weve 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 familys 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 familys 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.
Visit our to read more about the benefits ICON offers.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless 6 theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click to apply
