GxP Compliance Expert (m/f/d) - (S) for F. Hoffmann La Roche in Kaiseraugst

We make it GmbH; Kaiseraugst; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche is seeking a GxP Compliance Expert to join the Clinical Distribution team, driving GxP compliance and quality for the global Roche/Genentech study portfolio. You will manage deviations, CAPAs, and inspections, providing expert support across Deliver.

The ideal candidate has a university degree and extensive GxP experience, with strong regulatory knowledge, audit skills, and fluency in German and English. Experience with Veeva, Cornerstone, and QA tools is preferred.

Qualifikationen

• You hold a university degree in a relevant field with several years of solid experience in GxP compliance and the clinical supply chain.
• Proven expertise in regulatory requirements and quality standards, plus experience with audit/inspection processes.
• Strong communication and organisational skills with fluency in German and English.

Aufgaben

• Provide proactive GxP guidance and manage deviations/CAPAs/improvements.
• Act as the audit/inspection SME for Deliver across non-study specific examinations.
• Oversee regulated documents, and drive quality KPI ownership and training initiatives.
• Coordinate SOPs and other regulated documents across the department.
• Lead trend reporting for Quality and Compliance requirements.

Kenntnisse

GxP compliance

Regulatory inspections

Quality management

Audit experience

German language

English language

Ausbildung

University degree in a relevant field (BA/MS/MBA)

Tools

Veeva

Cornerstone

MS Office

Visio

Jobbeschreibung

Cybersteel Inc.
376-293 City Road, Suite 600
San Francisco, CA 94102

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Jobs

Datum: 21.09.2026

We make it GmbH is a company operating nationally in Switzerland. Thanks to many years of successful experience, it has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our customer, the company F. Hofmann La Roche, are we searching for:

GxP Compliance Expert (m/f/d) - (S)

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 (m/w/d): 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

Work hours

Standard / 40 hour week (3 days on site 2 days Home Office)

Tasks

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

Qualifications

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.

Are you interested?

Then Mr. Raphael Sigg looks forward to receiving your complete application documents (CV, certificates and training certificates). We look forward to hearing from you.