gxp compliance expert (m/f/d).

We are seeking an experienced professional with a relevant university degree and several years of solid working experience in GxP compliance and the clinical supply chain. The ideal candidate brings proven expertise in regulatory requirements and quality standards, along with experience in audit and inspection processes. Structured and customer-oriented working methods, strong communication skills, and fluency in both German and English are required.


General Information:
 

• Start Date: ASAP
• Latest Possible Start Date: 01.01.2027
• Planned Duration of Employment: 12 months
• Extension: possible
• Workplace: Kaiseraugst
• Workload:100%
• Home Office: up to 2 days/week
• Working Hours: Standard

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:
 

• University degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management)
• At least 6 years of professional experience
• Extensive knowledge of cGMP standards alongside hands-on experience navigating internal (PTQ, Pharma-Technical Quality) and external (e.g., FDA, EMA) regulatory inspections
• Deep understanding of end-to-end supply chain management, specifically encompassing warehouse and transportation management, logistics, and clinical supply chain distribution processes
• 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

Sounds interesting? Apply now! We are looking forward to receiving your application.