Job Description

Qualification and Validation Manager (m/f/d) - cGM / Operations, Qualification and Validation / Pharmaceutical Production Facilities / Laboratory Equipment / MS Office, Gsuite, Visio, eVal, Lucid Chart /

Veeva / eVal / German / English

Project

:
For our client, a large pharmaceutical company based in Basel, we are looking for a highly qualified Qualification and Validation Manager (m/f/d)

Background

:
Every patient has a right to quality, and every employee is responsible for quality. Quality gives us a competitive advantage and underlies everything we do - from concept to continuous improvement. Because our products impact people's lives, quality is the true measure of our success.

The Qualification Manager is responsible for the CSV and qualification program at Basel DS Manufacturing, as well as the activities to maintain qualified status in collaboration with engineering and operators at Basel Drug Substance Manufacturing (for biochemical and chemical manufacturing processes)...

The ideal candidate

will have a master's degree in chemical engineering, biotechnology, or a similar discipline and more than two years of experience in a pharmaceutical GMP environment. Furthermore, they will be familiar with the qualification and validation of pharmaceutical production facilities and laboratory equipment. Finally, they will possess strong IT skills and excellent German and English language skills.

Main tasks and responsibilities:

Management and coordination of CSV and qualification projects, approval of qualification plans and reports in eVal Creation of qualification strategies, risk analyses, qualification plans and reports Processing of changes, deviations, CAPAs, and preparation of technical assessments for stakeholders Development and implementation of improvement suggestions for device qualification and system validation concepts Representation of qualification and validation topics during regulatory inspections as well as in local and global networks, task forces, and project teams Collaboration with partners from site engineering, IT, manufacturing, and compliance departments Work in an environment with strong team spirit, timely and effective communication, a sense of urgency, and high motivation to achieve operational goals

Must Haves:

Master's degree in chemical engineering, biotechnology, a similar discipline, or chemical engineering At least 2 years of solid experience in the cGMP environment relevant to the pharmaceutical industry Experience in the operation, qualification, and validation of pharmaceutical production facilities and laboratory equipment Very good written and spoken German and English skills MS Office, Gsuite, Visio, eVal, Lucid Chart knowledge Excellent interaction with stakeholders Teamwork skills Sense of urgency

Nice to haves:

Veeva and eVal Roche experience
Reference No.: 924435SDA
Role: Qualification and Validation Manager
Industry: Pharma
Location: Basel
Workload: 100%
Start: 05.01.2026 (Latest possible start date: 01.12.2025)
Duration: 9+
Application deadline: 25.09.2025

Job Type: 100%

Work Location: On the road