Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)

Beschreibung

You will drive global quality by leading GxP audits and managing risk assessments. Your day-to-day involves collaborating across teams to ensure inspection readiness and refine auditing standards.

Anforderungen

• •Willingness for 50% international travel
• •Scientific degree or equivalent qualification
• •Six years' experience in pharmaceutical quality
• •Four years leading quality audits
• •Knowledge of pharmaceutical quality systems
• •Understanding of local and global regulations
• •Ability to analyze complex processes
• •Strong problem-solving and risk management
• •Experience in GxP or QMS
• •Competence in leading single-discipline audits
• •Experience working in international teams
• •Fluent written and spoken English
• •Proficiency with current digital tools

Aufgaben

• •Lead the planning and execution of GxP quality audits
• •Perform risk-based audit preparation and data mining
• •Develop audit agendas and document performance observations
• •Monitor and improve PV and Medical system audit metrics
• •Assess risks and evaluate corrective action responses
• •Approve audit reports and official records
• •Manage self-inspections and resolve resulting CAPAs
• •Support inspection readiness and due diligence activities
• •Collaborate with R&D and Pharmacovigilance on supplier audits
• •Drive continuous improvement for quality auditing processes
• •Participate in Communities of Practice and risk assessments
• •Train lead auditors on procedures and policies

Tools & Technologien

Benefits