Senior Manager, Quality Assurance

Third Party Quality Lead

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.

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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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve 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 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply