Third Party Quality Lead, Senior Manager - FSP

The Third Party Quality Lead (TPQL) at Parexel is responsible for managing third party quality risk, issues, and compliance in clinical trials, working with vendors and site entities to ensure quality systems and adherence to GCP and regulatory standards.

Location: Canada

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 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

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