Job Description

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. 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 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.: 924435

Role: Qualification and Validation Manager

Industry: Pharmaceuticals

Location: Basel

Workload: 100%

Start: January 5, 2026 (Latest possible start date: December 1, 2025)

Duration: 9+

Application deadline: November 6, 2025

Job Type: 100%

Work Location: On the road