Sr Director, Oncology Quality Risk Management Team Lead

ROLE SUMMARY:

• Lead as a player/coach the group of Oncology Quality Risk Management Leads and entire POD team as needed.

• Responsible for ensuring oversight of quality risk management activities for the Oncology portfolio and Pfizer QMS by building and managing a quality risk framework that establishes a regular review of quality risk metrics and enables the right culture that proactively identifies and manages quality risk.

• Work closely with the Quality team within Pfizer Research and Development (PRD) and other Pfizer teams as required to ensure alignment of Quality frameworks, governance, and operational support.

• Ensure thoughtful and timely implementation of Quality priorities by representing POD at key meetings and overseeing cross-functional POD projects.

ROLE RESPONSIBILITIES:

Quality Risk Management within Oncology Portfolio:

• Business ownership of the Oncology risk management framework, tools, technology, and processes.

• Maintaining visibility into enterprise-wide quality risks and signaling/flagging from various dashboards, and using this visibility to escalate risks to leadership

• Continuously improving risk-related technology and processes, specifically management reporting, information flow, business processes, and organizational planning, in support of Oncology quality.

• Aligning with Pfizer Research & Development (PRD) Quality for division of quality risk support responsibilities

• Drive consistent development of risk plans across studies in the Oncology portfolio; identify high-priority risks and risk trends to quality and provide expert consultation on risk management strategies.

• Influence development of new risks and evolving existing risks in relevant Quality Risk Management (QRM) tools.

• Provide feedback to QRM Business Process Owner (BPO) to continuously improve Integrated Quality Management Plan (IQMP) approach and other QRM process-related activities.

Oncology Quality Risk Management Oversight:

• Serve as escalation point for Oncology quality risk management leads.

• Represent Quality Risk Management at Pfizer Oncology Division level meetings.

• Represent Pfizer Oncology Quality at PRD Quality functional level and Enterprise leadership meetings.

• Ensure analysis and interpretation of quality data from multiple sources to identify key issues/risks at the portfolio level and across the Pfizer QMS. Communicate knowledge/trend information to relevant quality and portfolio governance committees.

• Maintain line-of-sight into quality risks and issues across oncology portfolio.

Escalation, Communication, and Governance:

• Set strategic framework for quality risk communication within Pfizer Oncology Division, including content and structure of leadership updates.

• Develop and present quality risk point of view at Pfizer Oncology Division governance meetings.

• Advise Oncology Quality Risk Management Leads, Oncology Vendor Management Leads, and Oncology Asset Quality Leads on appropriate escalation pathways for quality risk concerns.

• Escalate/communicate quality risks to:

  • Pfizer Oncology Division and PRD Quality Teams

  • Governance committees (e.g., GCP QOC, RDM QCC)

  • IPLT /Process Quality Leads for process level issues

• Advocate for Oncology Quality Risk Management team’s continuous improvement feedback on business processes to BPOs

• Work with PRD Quality for risk-related audit and inspection preparation.

Business Development:

• Partner with Pfizer Oncology Division and PRD leaders and cross-organization Quality leaders to assess development program strategy and key quality risks to inform the assessment of opportunities for oncology.

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

• Provide strategic input to risk-based quality approaches.

• Identify and, as needed, develop and maintain resources and applications supporting QRM activities.

Line Management:

• Leads and manages performance for an assigned group of Oncology Quality Risk Management Lead direct reports through goal setting, ongoing assessment, and coaching.

• Guide direct reports on relevant experiences to meet career objectives.

• Oversee contractors and cross-functional teams to ensure rapid implementation of POD priorities.

BASIC QUALIFICATIONS: