Strategic GCP Quality & Risk Management Lead

Denali Therapeutics; South San Francisco (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Scorpion Therapeutics in South San Francisco, CA is seeking a senior GCP QA leader to drive quality oversight across clinical development programs, ensuring compliance with ICH E6, GVP, and FDA regulations.

You will lead deviations, CAPAs, and risk management initiatives while mentoring teams and partnering with study teams to embed QbD and RBQM into processes, with a focus on inspection readiness and continuous improvement.

Qualifications

• Requires 12+ years GCP QA experience with bachelor’s degree, 10+ with master’s, or 7+ with PhD.
• Expertise in ICH E6, GCP, FDA regs and global requirements.
• Experience with QbD, RBQM, and QMS in clinical development.
• Proven leadership of GCP deviation, CAPA, and vendor qualification in a GxP environment.
• Strong analytical, communication, and cross-functional collaboration skills.

Responsibilities

• Lead GCP deviation and CAPA processes with timely investigations and closure.
• Partner with study teams to assess and mitigate quality risks using QbD and RBQM.
• Serve as SME on GCP quality risk management and noncompliance resolution.
• Oversee Clinical Trial Risk Tracking Program and escalation of risks.
• Analyze data, identify trends, and report insights to leadership.
• Review deviations and events to drive systemic improvements.
• Lead vendor qualification and ongoing GCP quality oversight.
• Support regulatory inspections with inspection readiness and responses.
• Enhance QMS by improving risk management processes and tools.

Skills

GCP QA leadership

ICH E6/GCP expertise

QMS & RBQM

Vendor qualification

Risk management

Cross-functional influence

Regulatory communications

Education

Bachelor’s degree in life sciences

Master’s degree in related field

PhD in life sciences

Tools

GxP systems

Quality management software

Job description

Scorpion Therapeutics in South San Francisco, CA is seeking a senior GCP QA leader to drive quality oversight across clinical development programs, ensuring compliance with ICH E6, GVP, and FDA regulations.

You will lead deviations, CAPAs, and risk management initiatives while mentoring teams and partnering with study teams to embed QbD and RBQM into processes, with a focus on inspection readiness and continuous improvement.