Group Head MSAT Equipment Qualification (Sterile Manufacturing)

Location: Fully site-based in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global develops and manufactures medicines and supports scientific breakthroughs that reach patients worldwide.

What you will do

• Lead the Equipment Qualification & Process Platforms function, including people, resources, capabilities, priorities, performance, delivery, coaching, talent development, and succession planning.
• Set strategic direction for equipment qualification and process platforms, translating site and business priorities into functional objectives and capability plans.
• Provide technical governance for sterile-manufacturing technologies including isolators, H₂O₂/VHP decontamination, thermal sterilization, filling and closing systems, and freeze-dryers.
• Own governance and lifecycle strategies for drug product process platforms covering thawing, compounding, mixing, sterilizing filtration, filling, stoppering, and crimping.
• Establish capabilities and governance for Single-Use Systems and maintain MSAT standards aligned with GMP, regulatory expectations, hirify.global standards, and industry practices.
• Represent MSAT as the senior technical authority in governance, customer interactions, audits, regulatory inspections, and Health Authority engagements; drive standardization and collaboration across global functions.

Requirements

• MSc or PhD in Pharmaceutical Sciences, Pharmaceutical Engineering, Chemistry, Bioengineering, Biochemistry, or a related discipline.
• Solid experience in sterile drug product fill-and-finish manufacturing environments is required.
• Expertise in equipment qualification, lifecycle management, process validation, aseptic manufacturing technologies, process platforms, and single-use systems.
• Strong knowledge of GMP and regulatory requirements, including experience supporting audits, Health Authority inspections, and technical interactions with internal and external stakeholders.
• Excellent communication, stakeholder management, influencing, and technical leadership skills, with the ability to align cross-functional teams and drive decisions in complex environments.
• Fluent English is required.

Nice to have

• German language skills.
• Previous people leadership experience.
• Passion for coaching, continuous improvement, and operational excellence.

Culture & Benefits

• Agile career environment and dynamic working culture.
• Inclusive and ethical workplace focused on ownership, collaboration, learning, and meaningful responsibility.
• Compensation programs recognizing high performance.
• Benefits vary according to role and location.
• In-person collaboration supports real-time teamwork and technical precision in medicine manufacturing.