Senior Director, GCS Inspection & Risk Management Lead

The Inspection and Risk Management Lead will drive the quality culture in Global Clinical Supply (GCS) by providing strategic leadership, oversight, and continuous improvement of key activities integral to Global Clinical Supply business quality and compliance efforts.  They are accountable for quality management activities, including establishing, managing, and maintaining GCS-wide practices with the goal of evolving quality approaches, reducing quality events, and contributing to compliant inspections and audits involving GCS.  

Focus areas include quality records management, quality metrics compliance, audits and inspection readiness and governance.

The IRM Lead develops talent by ensuring Quality Investigation Leads (QILs) and Inspection Readiness Leads (IRLs) are trained, supported, and positioned to deliver successfully. They ensure direct reports meet expectations, appropriately escalate risks, and drive process improvement.  They are accountable to ensure QILs and IRLs are following Pfizer Standard Operating Procedures (SOPs) and providing leadership and appropriate oversight to the matrix colleagues in the GSH hubs.
The IRM Lead directs trending and analysis of quality data to proactively identify risks, coordinates with GCS and Quality partners to resolve issues, and leads or supports Quality Governance.

As a Subject Matter Expert in quality investigations and inspection readiness, the IRM Lead fosters best practice sharing across teams.

The IRM Lead will interface as needed with key stakeholders across the organization including but not limited to GCS functional lines, PSOQ, other CD&O functional lines, RQA, Corporate Affairs, to ensure appropriate issue resolution/escalation and healthy stakeholder relationships.

The IRM Lead represents IRM and GCS in cross functional or enterprise level initiatives that influence senior leadership and strategic direction.  They are part of the IRM LT and GCS eLT, contributing to driving strategic initiatives to evolve IRM and GCS.This role is accountable and responsible for the following activities across all functions in Global Clinical Supply, with quality records, quality metrics, and audit and inspection as the focal point.

Line Management
* Manages, leads, and oversees the Inspection Readiness and Quality Investigation functions in IRM ensuring appropriate training through formal and experience-based assignments.  + Line management of GCS Quality Investigation Leads (QILs), including matrix management of hub colleagues  + Line management of GCS Inspection Readiness Leads (IRLs)  + Matrix management of the GSH Quality Management Specialists
* Actively develops and retains talent through provision of focused career development, performance management, and an inclusive culture
* Leads Hiring, Selection and Training of New Hires, and creates Training Plans for IR Leads and QI Leads.

Quality Investigations
* Main point of contact for all GCS related quality records
* Works with GCS functional lines, PSOQ and CD&O to ensure appropriate and timely processing and closure of records.
* Supports PSOQ procedural updates as needed, bringing the IRM and GCS line perspectives
* Supports the review and triage of GCP QE Assessment notifications.  Collaborates with GCS, PSOQ, and CD&O functions to ensure appropriate processing as needed.
* Determines strategy for appropriate documentation of quality issues, i.e., Quality Event, Deviation Record, CAPA Record, Change Management
* Escalates issues to Head of IRM, document actions.
* Oversees Quality Record assignments.
* Monitors workload and support Quality Investigation Leads to ensure a consistent, compliant, and timely investigation process.

Audits & Inspections
* Main point of contact for all GCS related audits and inspections
* Works with RQA, CA, and GCS and CD&O functional lines
* Leads standing internal IRM IR meeting to share learnings and discuss questions related to past and upcoming audits or inspections
* Oversee compliance with PTMF requirements, proactively monitoring metrics and communicating to GCS functional lines to ensure timely and quality submission of documents to proactively support audits and inspections.
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