The posting
Lead Quality Control (QC) - Sisslerfeld Site Develepoment (a) 100% #
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
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
Would you like to shape global Operational Readiness frameworks with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and our working environment at the Stein site on our website.
At Bachem, you-ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation-regardless of age, gender, background, religion, or sexual orientation.
