Sr Director, Oncology Quality Risk Management Team Lead

$191,300 - $318,800/Yr

Pfizer - New Salem Borough, PA

Full-time - Senior

New Salem Borough, PA

Chemical Manufacturing

About the position

As the Senior Director of Oncology Quality Risk Management, you will lead a team of Oncology Quality Risk Management Leads and the entire POD team, ensuring effective oversight of quality risk management activities for the Oncology portfolio and Pfizer's Quality Management System (QMS). Your primary responsibility will be to build and manage a comprehensive quality risk framework that facilitates regular reviews of quality risk metrics, fostering a culture that proactively identifies and manages quality risks. You will collaborate closely with the Quality team within Pfizer Research and Development (PRD) and other relevant Pfizer teams to ensure alignment of quality frameworks, governance, and operational support. Your role will also involve representing the POD at key meetings and overseeing cross-functional POD projects to ensure the timely implementation of quality priorities. In your capacity as a leader, you will take ownership of the Oncology risk management framework, tools, technology, and processes, maintaining visibility into enterprise-wide quality risks. You will utilize various dashboards to signal and escalate risks to leadership, continuously improving risk-related technology and processes to support Oncology quality. Your influence will be crucial in developing risk plans across studies in the Oncology portfolio, identifying high-priority risks, and providing expert consultation on risk management strategies. You will also serve as an escalation point for Oncology quality risk management leads and represent Quality Risk Management at Pfizer Oncology Division level meetings. Your strategic framework for quality risk communication will be essential in ensuring effective communication within the Pfizer Oncology Division. You will develop and present quality risk perspectives at governance meetings and advise various leads on appropriate escalation pathways for quality risk concerns. Additionally, you will partner with Pfizer Oncology Division and PRD leaders to assess development program strategies and key quality risks, driving the identification of quality risks related to acquisitions and incorporating them into study-level risk planning. As a line manager, you will lead and manage the performance of your direct reports, guiding them towards achieving their career objectives while overseeing contractors and cross-functional teams to ensure the rapid implementation of POD priorities.

Responsibilities

• Lead the Oncology Quality Risk Management team and ensure effective oversight of quality risk management activities.
• Build and manage a quality risk framework that establishes regular reviews of quality risk metrics.
• Collaborate with the Quality team within Pfizer Research and Development (PRD) and other teams to ensure alignment of quality frameworks and governance.
• Represent the POD at key meetings and oversee cross-functional POD projects to implement quality priorities.
• Maintain visibility into enterprise-wide quality risks and escalate risks to leadership as necessary.
• Continuously improve risk-related technology and processes to support Oncology quality.
• Drive the development of risk plans across studies in the Oncology portfolio and provide expert consultation on risk management strategies.
• Serve as an escalation point for Oncology quality risk management leads and represent Quality Risk Management at Pfizer Oncology Division meetings.
• Develop and present quality risk perspectives at governance meetings and advise leads on escalation pathways for quality risk concerns.
• Partner with Pfizer Oncology Division and PRD leaders to assess development program strategies and key quality risks.

Requirements

• A scientific or technical degree is preferred.
• Bachelors - 15+ years or equivalent experience; MS/MBA - 13+ years; PhD/PharmD/MD - 10+ years.
• Ability to build strong networks and relationships with internal and external stakeholders.
• Advanced knowledge and expertise in clinical trial development and operational quality management disciplines.
• Familiarity with the oncology therapeutic area is essential.
• Strong experience in project management and using standard applications supporting Quality activities.
• Demonstrated success working on global initiatives or project teams.

Nice-to-haves

• Experience with Program Management best practices.
• Ability to lead cross-line global initiatives for quality-related process improvement.
• Spotfire and Excel skills/experience.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage
• Participation in Pfizer's Global Performance Plan with a bonus target of 22.5% of the base salary
• Eligibility for share-based long-term incentive program
• Relocation assistance may be available based on business needs and/or eligibility.