Global Head of GCP Quality & Clinical Development Ops

Jobtailor; Connecticut; On-site; USD 300,000 - 420,000; Full time

Job summary

Pfizer seeks a senior GCP Quality leader to set and execute the long-term quality and integrity strategy for Clinical Development & Operations. You will govern risk-based quality frameworks, oversee the Quality Oversight Committee, and drive strategic recommendations to R&D leadership while ensuring readiness for inspections and regulatory interactions.

You will lead a globally distributed team, embedding quality by design and advanced analytics across the portfolio, while partnering with CROs,

Qualifications

• 12+ years in GCP quality, regulatory compliance, or related field.
• Proven leadership across global clinical development and operations.
• Experience guiding executive decision-making on regulatory and quality risks.
• Track record of enterprise-quality governance and remediation.
• Experience with AI/digital quality initiatives is a plus.

Responsibilities

• Define and execute Pfizer’s long-term GCP quality, compliance and integrity strategy for Clinical Development & Operations.
• Own the enterprise framework for assessing and communicating the state of GCP quality.
• Translate quality intelligence into strategic recommendations for CD&O and R&D leadership.
• Design and lead an integrated, risk-based GCP quality-governance model.
• Chair the GCP Quality Oversight Committee and elevate material risks and remediation priorities.
• Exercise independent judgment on high-risk clinical-development and business decisions.
• Provide strategic quality oversight across the global Phase I-IV portfolio.
• Ensure inspection readiness for pivotal trials, submissions and major regulatory interactions.

Skills

GCP Quality Strategy

Clinical Development Leadership

Regulatory Compliance

Risk Management

Global Clinical Trials

Quality Systems

Audits & Inspections

AI/Analytics in Quality

Vendor Management

Leadership

Education

Advanced degree in life sciences or regulatory

Job description

Pfizer seeks a senior GCP Quality leader to set and execute the long-term quality and integrity strategy for Clinical Development & Operations. You will govern risk-based quality frameworks, oversee the Quality Oversight Committee, and drive strategic recommendations to R&D leadership while ensuring readiness for inspections and regulatory interactions.

You will lead a globally distributed team, embedding quality by design and advanced analytics across the portfolio, while partnering with CROs,