Lead Quality Control for New Sisslerfeld Site

About the role

Lead the establishment and ramp‑up of the Quality Control organization for Bachem's new Sisslerfeld manufacturing site in Northwestern Switzerland. You will build laboratories, implement systems and ensure regulatory compliance throughout the project and operational phases.

Key responsibilities

• Build and lead the QC organization, including Microbiology (MIBI) and In‑Process Control (IPC) laboratories.
• Define and execute qualification, validation and implementation of analytical methods, equipment and laboratory systems (DQ, IQ, OQ, PQ).
• Develop and maintain QC documentation, procedures and governance across the site.
• Coordinate operational readiness activities and ensure a smooth transition from project to commercial operations.
• Oversee laboratory operations, resource planning and quality investigations (OOS, OOT, deviations, CAPAs, change controls).
• Represent QC during audits and inspections, ensuring inspection readiness and driving continuous improvement.

Required profile

• PhD or MSc in Chemistry, Pharmacy or a related scientific discipline.
• Minimum 7 years of relevant experience, including at least 5 years in a leadership role.
• Experience interacting with Swissmedic and other international regulatory authorities.
• In‑depth knowledge of EU GMP, Swiss Therapeutic Products Act, PIC/S, ICH and FDA regulations.
• Excellent written and spoken German and English.

Required skills

• Microbiology (MIBI) laboratory expertise.
• In‑Process Control (IPC) laboratory expertise.
• Qualification and validation of analytical methods and equipment (DQ, IQ, OQ, PQ).
• GMP compliance and regulatory affairs.

What we offer

• Dynamic, rapidly growing work environment with internal development opportunities.
• Employee development through internal and external training.
• 60% pension fund contribution by Bachem AG and optional extra‑mandatory pension plan.
• Access to benefits platforms, staff restaurant and free sports activities on the Bachem Campus.