Associate Director, R&D Quality Good Pharmacovigilance Practice

Scorpion Therapeutics; United States; Hybrid; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking a GVP Quality Lead to support pharmacovigilance QA within an oncology-focused biopharma. The role involves shaping global GVP QA frameworks to ensure regulatory compliance and inspection readiness.

You will lead audits, manage quality systems, and drive risk assessments, while coordinating cross-functional regulatory activities with Safety, Regulatory, Medical, and Clinical Ops.

Qualifications

• Bachelor's degree in a relevant field with 8+ years PV experience, or Master's with 6+ years.
• Expert knowledge of GVP and GCP regulations.
• Experience leading in a global, matrix environment.
• Strong analytical and audit skills.

Responsibilities

• Conduct and support PV QA activities.
• Lead audit and inspection processes.
• Develop and manage quality systems and risk assessments.
• Oversee vendor and subcontractor audits.
• Track metrics for continuous improvement.
• Coordinate cross-functional regulatory compliance with Safety, Regulatory, Medical, and Clinical Ops.

Skills

GVP knowledge

GCP knowledge

PV QA leadership

Audit & inspection

Regulatory compliance

Global/matrix environment

Analytical & process improvement

Education

Bachelor's degree

Master's degree

Tools

AI tools familiarity

Job description

Role

GVP Quality Lead supporting pharmacovigilance quality assurance within an oncology-focused biopharma, shaping global GVP QA frameworks to ensure compliance and inspection readiness.

Responsibilities

• conduct and support PV QA activities
• lead audit and inspection processes
• develop and manage quality systems and risk assessments
• oversee vendor and subcontractor audits
• track metrics for continuous improvement
• coordinate cross-functional regulatory compliance with departments like Safety, Regulatory, Medical, and Clinical Ops

Requirements

• Bachelor's degree and 8+ years PV experience, or Master's with 6+ years
• expert knowledge of GVP and GCP regulations
• proven ability to lead in a global, matrix environment
• strong analytical, audit, and process improvement skills

Preferred

• certifications in quality systems or auditing
• experience in oncology or related therapeutic areas
• familiarity with AI tools for process enhancement

High-Value

PV regulatory compliance, inspection readiness, global Quality Management, risk-based audits, vendor oversight, and experience supporting clinical development in oncology.

Work Setup

involves approximately 30% travel; location flexible within a global biotech framework.