Qualifizierungs- und Validierungsmanager

Qualification and Validation Manager (m/f/d) - cGM / Operations, Qualification and Validation / Pharmaceutical Production Facilities / Laboratory Equipment / MS Office, G Suite, 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 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 holds a Master's degree in chemical engineering, biotechnology, or a related field and has more than two years of experience in a pharmaceutical GMP environment. Furthermore, they are familiar with the qualification and validation of pharmaceutical production facilities and laboratory equipment. Finally, they possess strong computer 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
• Handling of changes, deviations, CAPAs, and creation of technical assessments for stakeholders
• Development and implementation of improvement proposals for equipment qualification and system validation concepts
• Representation of qualification and validation topics during regulatory inspections and in local and global networks, task forces, and project teams
• Collaboration with partners from site engineering, IT, manufacturing, and compliance departments.
• Working 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 related field, or chemical engineering
• Minimum of 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
• Excellent written and spoken German and English skills
• Proficiency in MS Office, G Suite, Visio, eVal, and Lucid Chart
• Excellent interpersonal skills with stakeholders
• Team player
• Sense of urgency

Nice to have:
• Veeva and eVal Roche experience

Reference No.: 924435SDA
Role: Qualification and Validation Manager
Industry: Pharmaceuticals
Location: Basel
Workload: 100%
Start: ASAP
Duration: 9+
Application Deadline: November 27, 2025

If this position has sparked your interest, please send us your complete application. If this position isn't quite the right fit and you'd prefer to be notified about other opportunities, you can also submit your application via this advertisement or to jobs[at]itcag[dot]com.
For more information about our company, our open positions, or our attractive payroll-only program, please contact us at +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with branches in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the IT, Life Science & Engineering sectors.
We offer both temporary staffing and payroll services. These services are free for our candidates, and we do not charge any additional fees for payroll.