Lead QC & Site Ramp-Up (Sisslerfeld)

Bachem Holding AG; Aargau; A distancia; CHF 170.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pension fund contributions

Pension Plan Plus

Staff restaurant

Partner discounts

Sports activities

Descripción de la vacante

Bachem Holding AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland and seeks a Lead QC to establish and lead the ramp-up of the Quality Control organization, ensuring regulatory compliance, operational readiness, and sustainable quality excellence.

The role demands a PhD/ MSc in a scientific field, about 7+ years of experience including 5+ years in leadership, plus strong Swiss and international regulatory interactions.

Formación

• PhD or MSc in Chemistry, Pharmacy, or related field.
• 7+ years of professional experience in the field, including at least 5 years in a leadership role.
• Experience interacting with Swissmedic and international regulatory authorities during audits and inspections.
• Deep knowledge of EU GMP, Swiss laws (HMG, AMBV), PIC/S, ICH, FDA requirements and related regulations.
• Excellent written and spoken German and English.

Responsabilidades

• Build, lead, and develop the QC organization for the Sisslerfeld Site, including Microbiology and IPC labs.
• Ensure regulatory and compliance requirements are implemented and aligned with stakeholders.
• Establish, implement, and improve QC systems, processes, and the quality framework.
• Drive qualification, validation, and implementation of analytical methods and laboratory systems.
• Develop and maintain site documentation governance and QC procedures.
• Coordinate operational readiness activities and transitions from project to commercial operations.
• Oversee ramp-up laboratory operations, QC processes, resource planning, and quality investigations during operations.
• Ensure inspection readiness and represent QC during audits and inspections.

Conocimientos

Leadership

Regulatory liaison

Quality mindset

Analytical thinking

Communication

Organizational skills

Problem solving

German language

English language

Educación

PhD or MSc in Chemistry/Pharmacy or related field

Descripción del empleo

Bachem Holding AG is expanding with a new Sisslerfeld manufacturing site in Northwestern Switzerland and seeks a Lead QC to establish and lead the ramp-up of the Quality Control organization, ensuring regulatory compliance, operational readiness, and sustainable quality excellence.

The role demands a PhD/ MSc in a scientific field, about 7+ years of experience including 5+ years in leadership, plus strong Swiss and international regulatory interactions.