GxP Compliance Expert

ITech Consult AG; Kaiseraugst; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche in Kaiseraugst seeks a GxP Compliance Expert to join the Clinical Distribution Team. You will drive GxP compliance across the Deliver chapter, provide proactive regulatory advice, manage deviations and CAPAs, and support inspections with SME guidance.

The role requires a university degree and extensive GxP and clinical supply chain experience, fluency in German and English, and hands-on familiarity with regulatory audits, quality systems such as Veeva, and KPI ownership.

Qualifikationen

• University degree in a relevant field with extensive experience in GxP compliance and the clinical supply chain.

Aufgaben

• SME for all GxP and compliance topics, incl system administration (Veeva quality docs)
• Audit/Inspection SME for Deliver for non-study examinations
• Process deviations, CAPAs, changes, and process improvements
• Quality KPI ownership for Deliver
• Deviation management improvement processes
• Root Cause Analysis (RCA) to address quality/regulatory issues
• Maintaining SOPs and other regulated documents
• Trend reporting across Quality and Compliance
• Implementing GxP training and developing employees' GxP knowledge

Kenntnisse

GxP compliance

German language

English language

Regulatory inspections

Quality management

Ausbildung

BA/MS/MBA in relevant field

Tools

Veeva

Cornerstone

MS Office

Visio

Google applications

Jobbeschreibung

GxP Compliance Expert - GxP / Compliance / Clinical Distribution Team / Managing deviations/CAPAs/improvements / GxP training / Root Cause Analysis (RCA / Englisch

Background:

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Clinical Distribution organisation's objective is to cost-effectively ensure the right product is in the right place at the right time every time, such that no patient will go without treatment and no clinical trial will be delayed.

The GxP Compliance Expert is a member of the Network & Capabilities Chapter within the Clinical Distribution Team (Deliver), which is jointly accountable for all elements of clinical supply chain distribution for the global Roche/Genentech portfolio of >500 studies. This role drives GxP compliance and quality within Clinical Distribution (Deliver). Key duties include proactive GxP advice, managing deviations/CAPAs/improvements, acting as the audit/inspection SME, handling regulated documents, analysing quality trends, and developing the team's GxP training.

The Perfect Candidate:

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.

Reference Information

• Reference Nr.: 925247
• Rolle: GxP Compliance Expert
• Industry: Pharma
• Location: Kaiseraugst
• Pensum: 100%
• Start: Asap ( latest start: 01.01.2027)
• Duration: 12++ months
• Deadline: 27/09/2026