Senior GCP Quality Strategy Lead

Scorpion Therapeutics; South San Francisco (CA); Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a senior Clinical Quality Assurance leader to own and drive GCP quality strategy across Study Execution Teams. You will partner with site leaders to mature site-level quality and ensure regulatory readiness, CAPA effectiveness, and risk-based monitoring.

Responsibilities include leading inspection strategy, guiding cross-functional teams, and overseeing CRO/vendor quality oversight to ensure ethics and patient safety are central to trial execution.

Qualifications

• Typically 12+ years related experience with a Bachelor’s degree (or equivalent combination).
• Experience developing/implementing/improving Quality Management Systems.
• Working knowledge of ICH E6 GCP, FDA CFR, and applicable global regulations.
• Experience supporting/leading regulatory inspections (FDA, EMA, MHRA, or others).
• Experience providing quality oversight of CROs, vendors, laboratories, and outsourced service providers.
• Ability to influence cross-functional teams in a matrix organization.
• Experience with ICH E6(R3) Quality by Design and Quality Risk Management.
• Excellent communication/presentation; ability to brief senior leadership and inspectors.
• Strong critical thinking to synthesize complex, ambiguous information to drive resolution.

Responsibilities

• Lead GCP quality strategy on assigned Study Execution Teams (SETs).
• Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence.
• Lead proactive quality risk assessments and drive risk mitigation throughout study execution.
• Own risk-based monitoring and analysis of quality issues; provide strategic guidance aligned with ICH-GCP and applicable global regulations.
• Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection responses, and CAPA effectiveness.
• Identify quality/compliance gaps, direct root cause analysis, drive CAPA development to resolution; oversee CAPA implementation, effectiveness reviews, and continuous improvement.
• Lead evaluation, selection, and ongoing quality oversight of CROs and clinical vendors.
• Design and continuously improve GCP Quality Systems, SOPs, and the Quality Management System.
• Develop inspection strategy documents, study storyboards, and inspection readiness tools.
• Own QA review of essential clinical trial documents; implement internal GCP QA processes and tools.
• Represent Clinical Quality Assurance in cross-functional initiatives and champion compliance, ethics, and patient safety.

Skills

Quality strategy

GCP & ICH E6

Regulatory inspections

CAPA & risk mgmt

CRO/vendor oversight

Cross-functional influence

Quality by Design

Communication to leadership

Education

Bachelor’s degree or equivalent

Tools

GCP QA processes

Job description

Scorpion Therapeutics seeks a senior Clinical Quality Assurance leader to own and drive GCP quality strategy across Study Execution Teams. You will partner with site leaders to mature site-level quality and ensure regulatory readiness, CAPA effectiveness, and risk-based monitoring.

Responsibilities include leading inspection strategy, guiding cross-functional teams, and overseeing CRO/vendor quality oversight to ensure ethics and patient safety are central to trial execution.