QC Site Lead: Build & Scale New GMP Lab

Bachem

Stein

On-site

CHF 150,000 - 210,000

Full time

7 hours ago

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Benefits offered by this job

Pension plan

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Staff restaurant

Gym & sports

Job summary

Bachem Group is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland. We seek a Lead QC to establish and ramp up the Quality Control organization, labs, and processes, ensuring regulatory compliance and readiness for commercial operations.

The role requires a PhD or MSc in a scientific field, strong leadership, and extensive experience with regulatory inspections and GMP guidelines. Fluency in German and English is essential for this cross-border project.

Qualifications

PhD or MSc in chemistry, pharmacy, or related field.
Minimum 7 years of professional experience in QC/QA with leadership of a team.
Experience with Swissmedic, EU GMP, and related regulatory standards.
Strong communication skills in German and English.

Responsibilities

Build and lead the QC organization for the Sisslerfeld Site.
Establish QC labs, systems, and applicable processes.
Ensure regulatory compliance and audits readiness.
Drive qualification, validation, and implementation of analytical methods and equipment.
Develop site documentation landscape and governance.
Coordinate operational readiness and transition from project to commercial operations.
Oversee ramp-up of laboratory operations and CAPA/change controls.