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GxP Compliance Expert

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VollzeitErfahrung nicht angegebenHybridAargau

Über diese Stelle

  • Life Sciences - Supply Chain / Operations
  • Aargau
  • Contracting
  • Vollzeit
  • Oct/Nov/Dec 2026 - 12-month contract (with the option of extension)
  • Clinical Supply Chain, GxP

Start Date: Oct/Nov/Dec 2026

End Date: 12-month contract (with the option of extension)

Workload: 100%

Location: Kaiseraugst

Work Model: Hybrid, three days on-site and two days working from home possible

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.

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