Asset Quality Lead (Director)

• Driving Level One quality for assets within one or multiple Oncology Franchise / tumor types by maintaining ‘quality’ line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio.  

• With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas within assets and across clinical trial programs. In partnership with the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset and study level quality oversight, drive quality risk management activities across an asset, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS.    

• They will be the initial escalation point for stakeholders and asset teams for asset and study quality risk management, quality issues management and general GCP guidance. 

ROLE RESPONSIBILITIES

Level 1 GCP Quality: 

• IQMP (Integrated Quality Management Plan) Development and Oversight at disease area and program level including integration within the Quality Management System (QMS), and ensuring individual asset and study level IQMPs are in place. 

• Escalation, Communication, and Governance – work within the Pfizer QMS framework, and in collaboration with PRD Quality, to ensure quality issues are escalated from study-level Asset Quality Leads and addressed appropriately. Represent their disease area / sub-portfolio within Pfizer Oncology Quality governance processes / meetings.  

• Inspection Readiness and Preparation, CAPA management – work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs. 

Other Responsibilities: 

• Provide single point of accountability to clinical teams in their tumor type(s) for GCP advice and guidance. 

• Strategically utilize quality and compliance data to monitor portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues and general quality state of asset/study. Analyze and interpret data from multiple sources to drive quality assessments. 

• Partner with Pfizer Oncology Clinical Development and Operations Analytics and Reporting and PRD Quality on the development and capture of quality metrics. 

• Provide Level 1 portfolio quality expertise on SQE investigation teams, as needed. 

• Design and execute Quality Compliance Assessments (QCA) within assets or CD&O process area and drive learnings across their tumor type(s). 

• Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities. 

• Oversee program and study-level quality risk management activities (including IQMP activity) in their tumor type(s). 

• Drive consistent implementation of IQMP across program and study teams. 

• Facilitate IQMP development. 

• Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner. 

• Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across Oncology Quality team. 

• Provide feedback to IQMP BPO to continuously improve IQMP approach. 

• Develop and present quality point<