GxP Compliance Expert

Gi Group UK; Kaiseraugst; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Pharmaceutical Client in Switzerland seeks a qualified GxP Compliance Expert for a temporary assignment starting immediately. You will lead GxP compliance activities across the clinical supply chain and serve as SME for audits and inspections.

The role requires a degree in a relevant field, 6+ years of experience, fluency in German and English, and strong knowledge of cGMP and regulatory inspections (FDA/EMA). You will work with Veeva and Cornerstone systems.

Qualifikationen

• Degree in a relevant field with significant experience.
• At least 6 years of professional experience in GxP/compliance.
• Extensive knowledge of cGMP and regulatory inspections (FDA/EMA).
• Deep understanding of end-to-end supply chain and logistics.
• Strong interpersonal and communication skills; customer focus.
• Fluency in German and English, written and spoken.
• Proficient with Veeva, Cornerstone, and common MS Office tools.

Aufgaben

• Serve as SME for GxP and compliance topics, including system administration.
• Act as Audit/Inspection SME for Deliver for non-study examinations.
• Process deviations, CAPAs, changes, and process improvements.
• Own Quality KPIs for Deliver and regulatory compliance.
• Drive deviation management improvement processes.
• Provide comprehensive compliance expertise and conduct RCA.
• Oversee SOPs and regulated documents; manage knowledge transfer.
• Lead trend reporting on Quality and Compliance requirements.
• Implement GxP training and develop employees' GxP knowledge.

Kenntnisse

GxP compliance

Regulatory inspections

Audit & CAPA

End-to-end supply chain

Stakeholder communication

German language

English language

Quality management

Ausbildung

BA/MS/MBA in Supply Chain/Pharma/Biology/Chemistry/Engineering

Tools

Veeva

Cornerstone

MS Office

Visio

Google applications

Jobbeschreibung

On behalf of our pharmaceutical client, we are currently seeking a qualified and motivated professional for a temporary assignment with an immediate start as a:

GxP Compliance Expert

For this position, 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.

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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