Senior QA Expert Audit Management 80-100%

Location: Stein, AG, Switzerland; primarily onsite 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 sites that manufacture medicines and support the development of breakthrough therapies.

What you will do

• Lead and coordinate Health Authority inspections and customer audits across the Stein manufacturing site and Basel QC laboratory.
• Plan audits, prepare documentation, coordinate stakeholders, host inspectors and auditors, and manage post-audit follow-up.
• Serve as the primary front-office representative during inspections and customer audits.
• Partner with subject matter experts and cross-functional teams on audit readiness and CAPA responses.
• Manage audit-related activities in TrackWise, including follow-up actions, compliance monitoring, and corrective-action closure.
• Support GMP compliance initiatives, self-inspections, change controls, non-conformities, document management, and Quality Management System improvements.

Requirements

• Proven experience managing Health Authority inspections, including Swissmedic inspections; FDA inspection experience is an advantage.
• Fluent German and English communication skills are required for working with inspectors, auditors, customers, and internal stakeholders.
• Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related life sciences discipline.
• Strong knowledge of GMP requirements in the pharmaceutical industry and experience driving inspection and audit readiness.
• Experience in sterile manufacturing and/or biologics manufacturing is highly desirable.

Culture & Benefits

• Agile career opportunities and a dynamic work culture.
• Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
• Compensation programs that recognize high performance.
• Lifestyle, family, leisure, and local benefits.