GxP Compliance Expert

Flexsis; Kaiseraugst; Hybrid; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Flexsis, on assignment with Roche in Kaiseraugst, seeks a reliable and motivated GxP Compliance Expert (m/f/d). Start ASAP, contract 12 months with possible extension 6–12 months. Hybrid work: 3 days on site, 2 days from home.

Fluent in German and English required. You will act as SME for GxP and compliance topics, support regulatory inspections, manage deviations and CAPAs, own quality KPIs, and oversee SOPs and regulated documents.

Qualifikationen

• Degree in a relevant field with significant senior experience.
• At least 6 years of professional experience.
• Extensive knowledge of cGMP standards and regulatory inspections (FDA/EMA).
• Strong end-to-end supply chain understanding: warehousing, transportation, logistics, and clinical supply.
• Excellent interpersonal, organizational, and prioritization skills with a customer focus.
• Fluent in German and English (written and spoken).
• Proficient with Google Workspace, MS Office, Visio, Veeva, and Cornerstone.

Aufgaben

• Serve as SME for GxP and compliance topics, including system administration (Veeva quality docs).
• Audit/Inspection SME for Deliver non-study examinations.
• Process deviations, CAPAs, changes, and process improvements.
• Own Quality KPI reporting for Deliver.
• Lead deviation management improvement initiatives.
• Provide comprehensive compliance expertise and RCA for quality issues.
• Manage SOPs and regulated documents across departments.
• Produce trend reports on Quality and Compliance.
• Implement GxP training and develop employee knowledge.

Kenntnisse

GxP compliance

Supply chain mgmt

German & English

MS Office / Google apps

Stakeholder comms

Ausbildung

BA/MS/MBA in a relevant field (e.g. SCM, Pharmacy, Biology, Chemistry)

Tools

Veeva

Cornerstone

Visio

MS Office

Google Apps

Jobbeschreibung

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.

For our client Roche in Kaiseraugst, we are looking for a reliable and motivated (m/f/d)

GxP Compliance Expert

• Start Date:ASAP
• Latest Possible Start Date: 01.01.2027
• Planned Duration of Employment: 12 month with an expected extension for another 6-12 months depending on the situation
• Home Office: Hybrid. 3 days on site 2 days HO

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.