Executive Director, Clinical Quality & Compliance

Scorpion Therapeutics; United States; On-site; USD 252,000 - 269,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Clinical QA leader to shape and execute the quality strategy for clinical programs. You will drive risk assessments, oversee audits, and ensure regulatory readiness across trials and post‑market activities.

The role requires deep GCP/GVP/GLP knowledge, hands‑on inspection experience across multiple jurisdictions, and the ability to mentor a growing QA team while partnering with cross‑functional stakeholders.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or related science field.
• 15+ years clinical sponsor QA experience; 8+ years in GCP management.
• Strong interpersonal, written and oral communication; compliance-focused teamwork.
• Experience hosting inspections across multiple jurisdictions (FDA, Canada, EMA, MHRA, Asia).
• Ability to lead teams, mentor staff, and manage resources effectively.

Responsibilities

• Develop and execute a clinical QA strategic vision aligned to programs.
• Lead risk management to ensure patient safety during trials and post‑market.
• Set goals, budgets, headcount plans, and performance metrics for Clinical QA.
• Anticipate regulatory changes and evolving GCP/GVP/GLP expectations.
• Serve as senior Clinical QA representative across program teams.
• Ensure global GCP/GVP/GLP compliance and apply CtQ principles (ICH E8(R1), E6(R2/R3)).
• Oversee quality systems development and coordination with GMP.
• Design and implement risk‑based audit programs (internal, CRO, sites).
• Evaluate audit findings and drive CAPA closure.

Skills

People management

GCP/GMP/GLP knowledge

Regulatory knowledge across regions

Communication & collaboration

Education

Bachelor's degree in life sciences or related field

Job description

Scorpion Therapeutics seeks an experienced Clinical QA leader to shape and execute the quality strategy for clinical programs. You will drive risk assessments, oversee audits, and ensure regulatory readiness across trials and post‑market activities.

The role requires deep GCP/GVP/GLP knowledge, hands‑on inspection experience across multiple jurisdictions, and the ability to mentor a growing QA team while partnering with cross‑functional stakeholders.