Senior QA Qualification Specialist/Manager (Pharmaceutical Drug Product)

Location: Visp, Switzerland; relocation assistance is available for eligible candidates and their families.

Company

hirify.global operates globally connected life-sciences manufacturing sites focused on producing medicines and viable therapies for customers.

What you will do

• Compile, review, and release qualification documents, including URS, qualification plans and reports, and DQ/IQ/OQ/PQ reports.
• Assess technical change requests and their impact on the qualified state of equipment, utilities, and systems.
• Support and approve quality risk analyses such as FMEA, investigate deviations, and drive CAPA and effectiveness checks to completion.
• Confirm qualified states through periodic reviews and re-qualification across facility, equipment, and system life cycles.
• Act as a subject matter expert, lead quality projects, write and maintain SOPs, and provide guidance to internal customers.
• Support audits, regulatory inspections, cGMP training, and the mentoring of junior quality professionals.

Requirements

• Academic degree in engineering, chemistry, biotechnology, or a related field.
• Significant pharmaceutical drug product industry experience, ideally in a QA role.
• Good understanding of applicable cGMP regulations and subject matter expertise in cGMP-compliant qualification.
• General knowledge of engineering and manufacturing processes, with the ability to work autonomously within established procedures.
• Excellent verbal, written, and interpersonal communication skills in German and English are required.
• Strong attention to accuracy and detail, teamwork, partnership, and individual decision-making skills.

Culture & Benefits

• Agile career opportunities and a dynamic work culture.
• Inclusive and ethical workplace with a focus on collaboration, accountability, excellence, passion, and integrity.
• Compensation programs recognizing high performance.
• Lifestyle, family, and leisure benefits tailored to the Visp location.