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 of view at governance meetings. 

• Guide asset/study team on appropriate escalation pathways for quality concerns. 

• Advocate for study teams’ continuous improvement feedback on business processes to BPOs. 

• Communicate key quality information (e.g., inspection/audit learnings) across asset/study teams and serve as asset quality expert) in their tumor type(s). 

• Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive in partnership with Audit and Inspection Quality. 

• Participate and guide teams with inspection preparation, conduct and response activities. 

• Support teams during inspections. 

BASIC QUALIFICATIONS  

• A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:  

• Bachelors – 14 years or equivalent  

• MS/MBA – 12 years or equivalent  

• PhD/PharmD/MD – 9 years or equivalent  

• Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines. 

• Expert knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness. 

• Ability to build strong network/knowledge/relationships with internal/external stakeholders. 

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. 

PREFERRED QUALIFICATIONS 

• Skilled in project management.  

• Strong interpersonal skills, ability to influence, and ability to build and maintain excellent working relationships across lines in a matrix organization.  

• Experience of working on global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.  

• Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement.  

• Ability to implement strategies using coordinated and transparent metrics to track and manage compliance.  

• Spotfire and Excel skills/experience.