Third Party Risk Lead Senior Manager
4 weeks ago
At Workingmums, we are committed to delivering safe and effective products to our patients. Our quality culture is flexible, innovative, and customer-oriented. As a member of our GCP Third Party Quality team, you will work with vendor leads and relevant site organization stakeholders for third party quality risk management, issues management, and general Good Clinical Practice guidance.
Key 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 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
- 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
- Bachelor's Degree
- Demonstrate extensive and relevant applicable experience in a similar role within the pharmaceutical industry
- Applicable pharmaceutical industry experience
- Robust knowledge in quality areas (i.e., audit, inspection, compliance, and inspection readiness fields)
- Demonstrated project management/leadership experience
- Quality related experience including working knowledge in:
- Quality and compliance management
- Root Cause Analysis
- Risk identification, controls, mitigations, and actions
- Metrics development and utilization
- Audit and Inspection conduct and CAPA response process
- Proficiency in Microsoft Office Suite
Work Location Assignment: Flexible working is possible from Pfizer sites. Applicable sites: Walton Oaks (Tadworth, Surrey), Thessaloniki (Greece), Cambridge (UK), Sandwich (UK) or Canada.
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