Associate Director, GVP Quality Assurance
Core
Conducting audits of Organon Processes, Affiliates, Vendors, and Business Partners to ensure quality and compliance with local and international regulatory requirements.
Role type
Senior IC Quality Assurance Auditor (GVP)
Builds
Compliance strategy and audit program effectiveness
Domain
Pharmaceutical industry + Quality Assurance/Regulatory Compliance
Required skills
GVP auditing, regulatory guidelines interpretation (EMA/FDA/ICH), audit planning and execution, risk-based strategy, stakeholder guidance, report generation, team mentorship
Preferred skills
Additional language skills, virtual environment work
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Schedule and conduct GVP audits, prepare audit reports and manage follow-up, maintain expertise in policies and regulations, lead audit program initiatives, support regulatory inspections, train and mentor junior members
Seniority
Senior, hands-on IC with leadership responsibilities
