GxP Compliance Expert

Tasks & Responsibilities:

• SME for all GxP and compliance-related topics (proactive advice on these matters) incl system administration (Veeva quality docs)
• Audit/Inspection SME for Deliver for non-study specific examinations
• Processing of deviations as well as CAPAs, Changes, Process Improvements
• Quality KPI Ownership for Deliver
• Responsibility for deviation management improvement processes
• Offer comprehensive compliance expertise to the business, conducting Root Cause Analysis (RCA) to identify and address quality, regulatory and compliance-related issues
• Managing the structure for the departments' SOPs and any other regulated documents (The business know-how is provided by the chapter’s SMEs)
• Responsibility for trend reporting across Quality and Compliance requirements
• Implementation of GxP training and further development of employees' GxP knowledge

Must Haves:

• You hold a degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management), backed by significant expertise and extensive years of senior professional experience.
• At least 6 years of professional experience
• You possess extensive knowledge of cGMP standards alongside hands-on experience navigating internal (PTQ, Pharma-Technical Quality) and external (e.g., FDA, EMA) regulatory inspections.
• You bring a deep understanding of end-to-end supply chain management, specifically encompassing warehouse and transportation management, logistics, and clinical supply chain distribution processes.
• You demonstrate strong interpersonal, communication, organisational, and prioritisation skills with a steadfast focus on customer needs.
• You are fluent in both written and spoken German and English.
• You are proficient in using Google applications, MS Office (Word, Excel, PowerPoint), Visio, and key industry systems such as Veeva and Cornerstone.