GxP Compliance Expert

ELAN Personal AG; Kaiseraugst; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Benefits dieser Stelle

Modern campus and green spaces

Central Basel location

Training and development opportunities

Zusammenfassung

Roche Switzerland is seeking a GxP Compliance Expert in Kaiseraugst/Basel to ensure quality and regulatory compliance across the Clinical Distribution Deliver organization. You will serve as SME for GxP topics, manage deviations and CAPAs, and drive training to enhance team capabilities.

The role requires 6+ years of senior experience, proficiency in German and English, and hands-on familiarity with Veeva and Cornerstone.

Qualifikationen

• Degree in a relevant field with significant senior experience.
• At least 6 years of professional experience.
• In-depth knowledge of cGMP and regulatory inspections (internal and external).
• End-to-end supply chain management including warehouse and transport.
• Strong interpersonal, organizational and prioritisation skills.
• Fluent in German and English (written and spoken).
• Proficient with Veeva, Cornerstone, MS Office, Google Apps and Visio.

Aufgaben

• Be SME for all GxP and compliance topics, including system administration (Veeva quality docs).
• Audit/Inspection SME for Deliver for non-study specific examinations.
• Manage deviations, CAPAs, changes and process improvements.
• Own Quality KPIs for Deliver and drive trend reporting.
• Lead deviation management improvement initiatives.
• Provide comprehensive compliance expertise to the business and conduct RCA.
• Maintain SOPs and other regulated documents for the department.
• Drive GxP training and develop employees' knowledge.

Kenntnisse

GxP compliance

Regulatory inspections

Root Cause Analysis

SOPs management

Quality KPI ownership

Stakeholder communication

Documentation handling

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

Cornerstone

MS Office

Google Apps

Visio

Jobbeschreibung

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst, we are looking for a

Background:

A healthier future. It’s what drives Roche 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.

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.

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

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining