Head, Clinical Development & Operations Quality

Summary

The Head, Clinical Development & Operations (CD&O) Quality is the senior leader accountable for defining and leading the global GCP quality, compliance and integrity strategy across Clinical Development & Operations. Reporting to the Head of Clinical Development & Operations and serving as a member of the CD&O Leadership Team, this leader provides independent, authoritative advice on the quality and regulatory risks associated with Pfizer's global clinical-development portfolio, operating model, technology strategy, external partnerships and organizational transformation.

The role holds enterprise accountability for the effectiveness and continued evolution of the GCP quality-management framework across clinical development, from first-in-human studies through post-approval commitments. The leader establishes the governance, standards, decision frameworks and management insights required to protect clinical-trial participants, preserve data integrity, maintain regulatory compliance and support reliable portfolio delivery across therapeutic areas, regions and operating models. The Head of CD&O Quality advises CD&O and R&D leadership on material quality risks and their implications for portfolio priorities, investment decisions, clinical-trial design and conduct, vendor and partner strategies, acquisitions and integrations, and the deployment of AI and digital capabilities.

The role has authority to escalation significant risks, require appropriate mitigation and challenge or recommend changes to business decisions when quality, compliance, participant protection or data integrity may be compromised. This leader represents CD&O in senior quality, compliance and risk-governance forums and maintains critical relationships with Regulatory Quality Assurance, Legal, Corporate Compliance, Digital, clinical-development leaders, health authorities and external partners.

The role builds a culture in which quality is embedded in business decisions and owned at every level, positioning quality as an enabler of innovation, speed and sustainable clinical-development performance rather than as a downstream control. The role leads a globally distributed organization of senior quality professionals and leaders, setting the long-term capability, talent, technology, resource and operating-model strategy required for a future-ready, data-driven and AI-enabled quality organization.

• Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O, aligned with Pfizer portfolio strategy, regulatory obligations, the Purpose Blueprint and the evolving clinical-development model.
• Own the enterprise framework through which CD&O assesses, understands and communicates its state of GCP quality, integrating leading and lagging indicators, emerging regulatory expectations, operational data, audit and inspection outcomes, and quality-event trends.
• Translate quality intelligence into strategic recommendations for CD&O and R&D leadership, including implications for portfolio priorities, operating-model design, capability investment, resourcing and risk acceptance.
• Executive Quality Governance and Decision Authority
• Design and lead an integrated, risk-based GCP quality-governance model with clear decision rights, escalation thresholds, accountability and interfaces across CD&O, R&D, Regulatory Quality Assurance, Legal, Corporate Compliance, Digital and other quality pillars.
• Chair the GCP Quality Oversight Committee and ensure material quality risks, systemic trends and remediation priorities are elevated to the appropriate executive governance bodies with clear recommendations and accountable decisions.
• Exercise independent judgment and constructive challenge when…