Third Party Risk Management Lead
4 weeks ago
About the Role:
We are seeking a highly skilled and experienced Senior Manager to lead our Third Party Quality team. As a key member of our GCP Quality team, you will be responsible for assessing and ensuring that clinical trial third party partners have the appropriate quality systems infrastructure.
Key Responsibilities:
- 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
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
- Audit and Inspection conduct and CAPA response process
About Pfizer:
We are a leading biopharmaceutical company that is committed to delivering innovative medicines and vaccines that improve the lives of patients around the world. We are proud to be a Disability Confident Employer and encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career.
What We Offer:
We offer a dynamic and inclusive work environment that values diversity and promotes work-life balance. Our company-wide digital transformation strategy is leading the way in adopting new data, modeling, and automated solutions to further digitize and accelerate drug discovery and development.
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