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
Evaluate quality performance at an enterprise level to inform continuous improvement of quality risk management
Inform 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

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: 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

Senior Manager, Third Party Quality - FSP

Key skills