Assistant/Associate Director, Pharmacovigilance Quality Assurance
Job in
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
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
- 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%)
- experience with PV service provider oversight
- data integrity
- GxP systems
focus on clinical and post-market PV, global regulatory compliance, audits, inspection readiness, and cross-functional PV support in biotech/pharma settings.
Work setupremote US-based with travel.
Position Requirements
10+ Years
work experience
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