GxP Compliance Expert (m/f/d)

Work Selection AG; Kaiseraugst; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

On-site parking

Meals in staff restaurants

Professional onboarding program

Staff discounts

Fleet discounts

Zusammenfassung

Work Selection AG seeks a GxP Compliance Expert for a 12-month assignment at its partner, Roche in Kaiseraugst. The role includes SME guidance on GxP topics, audits, and deviation management within a robust quality framework.

Ideal candidates hold a relevant degree and 6+ years in cGMP, with fluency in German and English, and strong MS Office, Veeva, Cornerstone skills. On-site work with onboarding days and development opportunities.

Qualifikationen

• Degree in a relevant field (e.g. Supply Chain Mgmt, Pharmacy, Biology, Chemistry).
• Significant senior experience (6+ years).
• Knowledge of cGMP standards and regulatory inspections (FDA/EMA).
• Strong cross-functional collaboration and stakeholder management.

Aufgaben

• Serve as SME for GxP and compliance topics, incl system administration (Veeva docs).
• Act as Audit/Inspection SME for non-study examinations.
• Process deviations, CAPAs, changes and process improvements.
• Own Quality KPIs for Deliver and drive trend reporting.
• Lead deviation management improvement initiatives and RCA actions.
• Provide comprehensive compliance expertise to address quality and regulatory issues.
• Maintain SOPs and regulated documents across the department.
• Support GxP training and development of staff knowledge.

Kenntnisse

GxP Compliance

Interpersonal skills

Communication skills

Organisational skills

Prioritisation

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

Cornerstone

Google Apps

MS Office

Visio

Jobbeschreibung

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Kaiseraugst, we are currently looking for a motivated and dedicated GxP Compliance Expert for a temporary assignment of 12 months, with high probability of extension.

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.

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card