Beschreibung

In this role, you will ensure inspection readiness and drive quality improvements by managing audits, leading risk assessments, and maintaining compliance with quality standards. Your expertise will be crucial in enhancing the Quality Management System.

Anforderungen

• •8-10 years of experience in Quality Assurance and Compliance within a GMP-regulated pharmaceutical environment
• •Experience leading and managing health authority inspections with FDA and Swissmedic inspectors
• •Strong background in pharmaceutical GMP manufacturing, ideally sterile manufacturing
• •Proven expertise in Quality Risk Management (QRM), including ownership and governance of risk registers
• •In-depth knowledge of GMP regulations, guidelines, and industry best practices (e.g. EU GMP, FDA, ICH, Annex 1)
• •Strong leadership, communication, and stakeholder management skills
• •Structured, resilient, and confident in high-pressure regulatory situations
• •Experience with customer audits as a CDMO is a plus
• •Fluent in written and spoken English, German as a plus

Aufgaben

• •Plan and coordinate health authority inspections
• •Perform and track customer audits and self-inspections
• •Act as the primary QA contact during inspections
• •Prepare and manage CAPA plans with stakeholders
• •Own and manage core quality processes
• •Lead Quality Risk Management activities
• •Conduct risk assessments and develop mitigation strategies
• •Establish and maintain the risk register
• •Document, review, and escalate risks appropriately
• •Support continuous improvement of QMS processes
• •Author, review, and approve SOPs and quality documentation
• •Support follow-up activities for inspections

Benefits