QC Lead for New GMP Site Development (Sisslerfeld)

Bachem Holding AG; Stein; On-site; EUR 139,000 - 204,000; Full time

Benefits offered by this job

Development opportunities

Pension fund contributions

Staff restaurant

Internal training opportunities

Campus sports activities

Job summary

Bachem Holding AG is developing a new Sisslerfeld manufacturing site in Northwestern Switzerland. We seek a Lead QC Sisslerfeld Site Development (a) 100% to establish and lead the ramp-up of the QC organization, ensuring regulatory compliance and operational readiness.

You will build and develop QC labs (MIBI, IPC), drive method qualification/validation, maintain QC documentation, and coordinate readiness activities with stakeholders to enable a smooth transition from project to commercial

Qualifications

• PhD or MSc in a scientific discipline (Chemistry, Pharmacy, or related).
• Minimum 7 years of professional experience in QC with at least 5 years in leadership.
• Experience with Swissmedic and international regulatory audits.
• Knowledge of EU GMP, HMG/AMBV, PIC/S, ICH, and FDA requirements.

Responsibilities

• Build, lead, and develop the QC organization for the Sisslerfeld site, including Microbiology and IPC labs.
• Drive qualification, validation, and implementation of analytical methods and lab systems.
• Ensure regulatory compliance and inspection readiness across audits and inspections.
• Define operational readiness milestones and coordinate with stakeholders during project to production transition.
• Oversee QC processes, deviations, CAPAs, and change controls in the operational phase.

Skills

Leadership

Regulatory knowledge

German & English fluency

Education

PhD or MSc in Chemistry/Pharmacy

Tools

GMP systems

Job description

Bachem Holding AG is developing a new Sisslerfeld manufacturing site in Northwestern Switzerland. We seek a Lead QC Sisslerfeld Site Development (a) 100% to establish and lead the ramp-up of the QC organization, ensuring regulatory compliance and operational readiness.

You will build and develop QC labs (MIBI, IPC), drive method qualification/validation, maintain QC documentation, and coordinate readiness activities with stakeholders to enable a smooth transition from project to commercial