GxP Compliance Expert (m/f/d) - Clinical Supply Chain

Randstad Switzerland

Kaiseraugst

Hybrid

CHF 140,000 - 190,000

Part time

6 days ago
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Benefits offered by this job

Home office 2 days/week
12-month contract with possible ext.

Job summary

Randstad Switzerland is seeking a GxP Compliance Expert for a leading pharmaceutical client. You will act as SME on GxP and regulatory topics with a focus on the clinical supply chain, audits, CAPAs, and process improvements. Fluency in German and English is required.

You will manage deviations, CAPAs, and SOP governance while implementing RCA-driven improvements and delivering quality KPIs. The role offers home-office flexibility up to two days per week and a 12-month contract with potential

Qualifications

  • University degree in a relevant field (e.g., Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering & Management).
  • At least 6 years of professional experience in GxP compliance and related audit/inspection activities.
  • Extensive knowledge of cGMP standards and experience with internal and external regulatory inspections (FDA, EMA).
  • Deep understanding of end-to-end supply chain management including warehouse, transportation, logistics, and clinical distribution.
  • Fluent in German and English, strong communication and organizational skills.
  • Proficient with Google applications, MS Office (Word, Excel, PowerPoint), Visio, Veeva, Cornerstone.

Responsibilities

  • Serve as SME for GxP and compliance topics, including system administration (Veeva quality docs).
  • Audit/Inspection SME for deliverables and inspections.
  • Process deviations, CAPAs, changes, and process improvements.
  • Own Quality KPIs for Deliver and drive trend reporting across Quality and Compliance.
  • Lead RCA to address quality and regulatory issues.
  • Oversee SOPs and regulated documents, ensuring business knowledge captured by SMEs.
  • Develop and deliver GxP training to employees.

Skills

GxP compliance
Regulatory inspections
Root Cause Analysis
Quality KPI ownership
Audit/Inspection SME
Deviation/CAPA management
Supply chain end-to-end
Communication skills
German & English fluency

Education

BA/MS/MBA in Supply Chain Management/Logistics or related fields

Tools

Veeva
Cornerstone
MS Office
Visio
Google applications

Job description

On behalf of our client, a leading pharmaceutical company, we are currently looking for a GxP Compliance Expert.

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:
  • Planned duration: 12 months
  • Contract type: temporary contract via Randstad (employment)
  • Extension: possible
  • 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
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