About this role

For one of our clients, a leading global pharmaceutical company, we are currently looking for a Qualification and Validation Manager.

General Information:

Start date: 05.01.2026
Duration: until 30.09.2026
Workplace: Basel
Workload: 100%
Remote/Home Office: possible, max 20%
Working hours: Standard
Department: MSAT (MMNGF)
Team: 10 people

About the job:

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 the engineering and operators at Basel Drug Substance Manufacturing (for biochemical and chemical manufacturing processes).

Your Profile:

Master's degree in chemical engineering, biotechnology, or a similar discipline and more than two years of experience in a pharmaceutical GMP environment.
Familiarity with the qualification and validation of pharmaceutical production facilities and laboratory equipment.
strong IT skills and excellent German and English language skills.

Tasks & 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 creation of technical assessments for stakeholders
Development and implementation of suggestions for improvements to the device qualification and system validation concepts
Representation of qualification and validation topics during authority inspections as well as in local and global networks, task forces or project teams
Collaboration with partners from site engineering, IT, manufacturing companies and compliance departments.
Work in an environment with a strong team spirit, timely and effective communication, a sense of urgency and a high motivation to achieve the company's goals

Must Haves:

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

Nice to haves: