QA Sterility Assurance Manager (Sterile Manufacturing)

Location: Stein, AG, Switzerland. Primarily site-based, with remote work permitted for no more than 20% of the time. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global operates globally connected life-sciences manufacturing sites that develop and produce medicines and therapies for customers.

What you will do

• Lead the site's sterility assurance strategy and ensure compliance with EU GMP Annex 1 and other global regulatory requirements.
• Develop and continuously improve the Contamination Control Strategy, including contamination control, environmental monitoring, cleaning, disinfection, and aseptic manufacturing activities.
• Provide sterility assurance expertise for facility design, qualification, validation, technology transfers, new product introductions, and innovative technologies.
• Lead risk assessments, trend analysis, training programs, and continuous improvement initiatives.
• Represent Quality Assurance during inspections, audits, and regulatory interactions while supporting cross-functional collaboration.

Requirements

• Proven expertise in sterility assurance within a sterile manufacturing environment.
• Hands-on experience implementing and maintaining EU GMP Annex 1 requirements.
• Strong knowledge of Contamination Control Strategy and contamination control programs.
• Extensive experience with aseptic processing, media fills, contamination risk management, and sterile manufacturing operations.
• Proactive, solution-oriented approach with experience identifying root causes and implementing corrective actions.
• Fluent English and confidence representing the organization during audits and inspections.

Nice to have

• German language skills.
• Audit experience.

Culture & Benefits

• Agile career opportunities and a dynamic work culture.
• Inclusive and ethical workplace.
• Compensation programs recognizing high performance.
• Lifestyle, family, and leisure benefits.