Senior Asset Quality Lead, Inspections (Director)

The Senior Asset Quality Lead, Inspections (AQL) is responsible for driving GCP Quality by maintaining ‘quality’ line-of-sight for assigned asset/franchise The Senior Asset Quality Lead /TA. With this focus, the sAQL role brings deep knowledge of GCP quality and risk management principles to asset and study teams. In partnership with the cross functional study team and functional lines in Clinical Development & Operations, the sAQL will ensure asset and/or franchise quality oversight, drive quality risk management and inspection readiness activities and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS. The sAQL is the point person to the cross functional asset/franchise and other relevant stakeholders for quality risk management, quality issues management and general GCP guidance. The sAQL may also provide protocol level quality support. The sAQL may also serve a subject matter expert within CD&O Quality and represent the group at relevant initiatives/governances.

Asset/Franchise-Level Quality Oversight

 · Provide input and support to asset-assigned AQLs to ensure clinical development plan strategy and asset-level risks are incorporated into study and asset-level risk management and oversight to support GCP compliance

· Strategically utilize quality measures/data to monitor asset/franchise quality and identify potential risks/quality trends across the asset/franchise and report out to applicable governance bodies

· Serves as point of escalation for GCP quality accountability within asset/Franchise

· Monitor submission risk and flag major risks for Category Quality Head review and other key stakeholders for review.

Asset/Franchise-Level Oversight of Study-Level Risk Management Plan Development

· Ensure consistency of the study risk plans across the asset and/or franchise, including relevant vendor and site level risks.

 · Develop and present quality point of view at governance and portfolio related meetings Inspection Readiness, Preparation and Support

· Provide strategic expertise to AQLs/study teams as they complete Inspection Readiness (IR) activities

· Develop and maintain Pfizer’s inspection readiness strategy including tools and processes.

· Train and mentor AQLs regarding inspection support activities and development of written responses to findings.

· In conjunction with IMQA, coordinate business line inspection support activities including but not limited to requests for dossiers, pre-inspection requests, during inspections and through the development of written responses to findings.

Business Development/Integration/Divestitures

· GCP quality representative of the PRD due diligence team for business development opportunities.

· Partner with PRD leaders and cross-organization Quality leaders to assess development program strategy and key quality risks to inform the assessment of opportunities for the category

· Drive identification of key quality risks and proposed mitigations related to acquisitions and incorporate into study level risk planning as well.

· Provide strategic input to risk-based quality approaches

· Provide quality leadership during integration activities

 · Lead Quality Integration activities including but not limited to: representing quality functional lines at integration workshops or operational workshops, leading the GCP Quality Integration sub-team, developing and leading GCP Quality Integration Workstreams, and managing quality project plans for GCP business deal activities (e.g., integration operations).

Escalation, Communication, and Governance

· Set strategic framework for quality communication within asset/franchise, including content and structure of leadership updates

· Develop and present quality point of view at governance meetings

 · Advise asset/study team on appropriate escalation pathways for quality concerns

 · Communicate key quality information (e.g. inspection/audit learnings) across asset/franchise and serve as asset quality expert

· Represent Category Quality Management at Category level meetings and other functional level leadership meetings, as delegate for Category Quality Head

· Lead asset level/franchise level quality risk planning activities

· Support Category Quality Head in defining optimal resourcing strategy and GCP quality support within Category.

support within Category

Subject Matter Expertise

· Serve as a CD&O Quality point of contact and technical expert for Quality related processes and/or systems (could include inspection readiness/support; business development/ integrations; quality risk management; regulatory interaction/response management)

· Accountable for maintaining training and CD&