Assistant/Associate Director, Pharmacovigilance Quality Assurance

Scorpion Therapeutics; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking an Assistant/Associate Director, Pharmacovigilance Quality Assurance to lead PV QA activities across development and post-market safety processes.

The role emphasizes risk-based QA programs, audits of PV providers and internal processes, audit reporting, inspection readiness, CAPA effectiveness, and PV guidance across clinical safety functions, with some travel required.

Qualifications

• Bachelor's degree in life sciences or related field; 8+ years in GVP QA or clinical safety for Assistant Director, 12+ years for Associate Director.

Responsibilities

• Lead risk-based GVP QA programs across development and post-market safety processes.
• Conduct and support audits of PV service providers and internal processes.
• Prepare audit reports and ensure inspection readiness.
• Oversee CAPA effectiveness and monitor quality metrics.
• Provide PV QA guidance and training across clinical safety functions.
• Support regulatory inspections and cross-functional PV activities.

Skills

GVP audits

Regulatory knowledge (FDA/EMA)

Audits management

Communication skills

Organizational skills

Travel willingness

Education

Bachelor's degree in life sciences or related field

8+ years PV QA experience (Assistant Director) or 12+ years (Associate Director)

Tools

Audit management tools

Job description

Role

Assistant/Associate Director, Pharmacovigilance Quality Assurance, leading PV QA activities within development and post-market safety processes.

Responsibilities

• implement and maintain risk-based GVP-compliant QA programs
• conduct and support audits of service providers and internal PV processes
• prepare audit reports
• ensure inspection readiness
• oversee CAPA effectiveness
• provide PV QA guidance, training, and oversight across clinical safety functions
• develop quality metrics and support regulatory inspections

Requirements

• Bachelor's degree with 8+ years (Assistant Director) or 12+ years (Associate Director) experience in GVP QA or clinical safety
• strong GVP audit background, knowledge of global PV regulations (FDA, EMA), GCP, and clinical development
• experience supporting inspections and audit management
• effective communication and organizational skills
• willingness to travel (~10-15%)

Preferred

• experience with PV service provider oversight
• data integrity
• GxP systems

High-value

focus on clinical and post-market PV, global regulatory compliance, audits, inspection readiness, and cross-functional PV support in biotech/pharma settings.

Work setup

remote US-based with travel.