Global Head of GCP Quality & Clinical Development

Scorpion Therapeutics; New York (NY); On-site; USD 300,000 - 500,000; Full time

Benefits offered by this job

Base salary range

Bonus plan

401(k) with company match

Paid time off

Relocation support

Medical/dental/vision

Job summary

Scorpion Therapeutics seeks a senior GCP quality leader to set and drive the long-term quality, compliance and integrity strategy for CD&O. You will own enterprise quality governance, lead the GCP Oversight Committee, and ensure readiness for pivotal trials and regulatory engagements across a global Phase I–IV portfolio.

You will influence executives on high-stakes regulatory and data integrity risks, shape AI/digital quality frameworks, and advance quality by design across planning, operations,

Qualifications

• 12+ years advanced scientific/medical/pharmacy/regulatory/quality experience (or equivalent).
• Extensive leadership in GCP quality, clinical development/operations, and regulatory compliance; experience directing senior leaders in a global setting.
• Deep expertise in Phase I-IV trial conduct and applying GCP requirements across major jurisdictions.
• Enterprise accountability for quality strategy, clinical quality systems, portfolio risk management, inspections and remediation.

Responsibilities

• Set and execute the long-term GCP quality, compliance and integrity strategy for CD&O.
• Own the enterprise framework to assess, communicate and improve GCP quality state (indicators, audits, risk trends).
• Translate quality intelligence into strategic recommendations for portfolio priorities and capabilities.
• Design and lead a risk-based GCP quality-governance model with clear decision rights and escalation.
• Chair the GCP Quality Oversight Committee and elevate material risks to executive governance.
• Provide strategic oversight across global Phase I-IV portfolio focusing on participant/data integrity/regulatory risk.
• Ensure inspection readiness for pivotal trials/submissions and represent quality in sponsor inspections.
• Lead AI/digital quality frameworks: lifecycle management, explainability, data integrity and regulatory readiness.
• Embed quality by design across planning, protocol, vendor models and technology transformation.
• Establish third-party/GCP risk governance; lead due diligence, contracting expectations and oversight.
• Provide executive leadership for systemic remediation and organizational learning.
• Lead globally distributed quality organization, talent strategy and accountable delivery.

Skills

GCP quality leadership

Clinical development

Regulatory compliance

Executive influence

Quality strategy

AI quality

Governance

Audits & inspections

Cross-functional

Risk management

Quality governance

Job description

Scorpion Therapeutics seeks a senior GCP quality leader to set and drive the long-term quality, compliance and integrity strategy for CD&O. You will own enterprise quality governance, lead the GCP Oversight Committee, and ensure readiness for pivotal trials and regulatory engagements across a global Phase I–IV portfolio.

You will influence executives on high-stakes regulatory and data integrity risks, shape AI/digital quality frameworks, and advance quality by design across planning, operations,