Lead Quality Control (QC) - Sisslerfeld Site Develepoment (a) 100%

Bachem; Stein; On-site; CHF 150,000 - 210,000; Full time

Benefits offered by this job

Pension plan

Discount platform

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.

Education

PhD in Chemistry/Pharmacy

MSc in Chemistry/Pharmacy

Tools

Laboratory leadership

Job description

The Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization.

As part of the development of our new Sisslerfeld manufacturing site, we are looking for a Lead QC Sisslerfeld Site Develepoment (a) 100%. In this key role, your focus will be to establish and lead the ramp-up of the Quality Control organization, driving the successful setup of laboratories, systems, and processes while ensuring regulatory compliance, operational readiness, and sustainable quality excellence.

Your tasks

• Build, lead, and continuously develop the Quality Control organization for the Sisslerfeld Site, including the establishment of Microbiology (MIBI) and In-Process Control (IPC) laboratories.
• Ensure implementation of regulatory and compliance requirements and support alignment with internal and external stakeholders throughout project execution.
• Establish, implement, and continuously improve QC systems, processes, and the quality framework.
• Drive qualification, validation, and implementation of analytical methods, technologies, equipment, and laboratory systems, including support of C&Q activities (DQ, IQ, OQ, PQ).
• Develop and maintain the site documentation landscape in the area of responsibilities, including QC procedures, applicable regulations, roles, responsibilities, and documentation governance across all applicable areas.
• Define and coordinate operational readiness activities, milestones, and business processes to ensure successful transition from project to commercial operations.
• Oversee and continuously improve the ramp-up laboratory operations, QC processes, resource planning, and quality investigations (OOS, OOT, deviations, CAPAs, and change controls) during operational phase.
• Ensure inspection readiness, represent Quality Control during audits and inspections, and collaborate with Global Quality and site stakeholders to drive continuous improvement initiatives.

Your profile

• PhD or MSc in a scientific discipline (Chemistry, Pharmacy, or a related field).
• Minimum of 7 years of professional experience in the relevant field, including at least 5 years of leadership experience managing a team.
• Experience interacting with Swissmedic and international regulatory authorities during audits and inspections.
• In-depth knowledge of regulatory requirements, including EU GMP Guidelines, the Swiss Therapeutic Products Act (HMG) and the Ordinance on Establishment Licences (AMBV), PIC/S Guidelines, ICH Guidelines, FDA requirements, and related regulations.
• High level of commitment and dedication to the organization.
• Enthusiasm for building and establishing a new GMP manufacturing site with a pioneering mindset.
• Strong and effective communication skills.
• Excellent organizational skills, with the ability to prioritize tasks and manage multiple responsibilities simultaneously. This is critical to supporting smooth site operations, especially during the project phase.
• Strong problem-solving skills, with the ability to quickly identify issues, think analytically, and develop pragmatic yet compliant solutions to effectively address challenges.
• Flexibility and adaptability, recognizing that priorities and responsibilities may change throughout different project phases.
• Excellent written and spoken German and English language skills.

Our offer:

• A dynamic and rapidly growing work environment with internal development opportunities
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the benefits platforms with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus