Job Overview

The Third Party Quality Lead (TPQL) reports to the Head of Third Party Quality. The TPQL works with stakeholders and relevant oversight teams for third party quality risk management, issues management and general Good Clinical Practice guidance. The TPQL maintains Quality-to-Quality contacts with major vendors and site entities partnering with Clinical Development & Operations (CD&O). The TPQL is responsible for assessing and ensuring that clinical trial third party partners have the appropriate quality systems infrastructure, including a culture of quality and compliance to adhere to sponsor's policies and procedures with all applicable external regulatory requirements relating to GCP including those related to patient safety, data integrity, and protocol adherence as set out in the Master Services Agreement. The TPQL the vendor engagement framework, including processes, tools, roles and sourcing strategy.

Job Responsibilities:

Third Party Quality & Risk Management

• 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 sponsor's 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

Qualifications:

• BS--7+ years or equivalent
• MS/MBA – 6+ years or equivalent

Previous Experience:
• 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:
o Quality and compliance management, QC
o Root Cause Analysis
o Risk identification, controls, mitigations, and actions
o Metrics development and utilization
o 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