Specialist Quality Operations (Biotech Manufacturing)

Location: Yverdon-les-Bains, Switzerland; onsite presence in manufacturing classified areas is required.

Company

hirify.global operates a large-scale biological manufacturing facility producing monoclonal antibodies.

What you will do

• Provide day-to-day quality oversight for USP and DSP manufacturing, washing activities, and media and buffer preparation.
• Review batch records and recommend batch disposition within defined timelines.
• Review and approve manufacturing SOPs, Master Batch Records, deviations, investigations, CAPA plans, and change implementations.
• Ensure compliance with cGMPs, approved procedures, documentation controls, and production materials traceability.
• Perform GMP tours and GEMBA activities, track corrective actions, and represent QA in manufacturing meetings.
• Partner with manufacturing and internal stakeholders to support right-first-time operations, regulatory compliance, and continuous improvement.

Requirements

• Academic degree in pharmacy, chemistry, biotechnology, engineering, or another natural or applied science.
• At least 3 years of Quality Operations experience in pharmaceutical manufacturing sites.
• Thorough knowledge of cGMP and international regulatory requirements, with an understanding of biotech processes.
• Experience with international inspections, analytical problem solving, and structured communication.
• Fluent written and spoken French is required; a good level of English is ideally expected.
• Compliance-focused approach; internal auditor qualification is an asset.

Culture & Benefits

• Close collaboration with BioPlant and other internal functions.
• Active promotion of quality, business integrity, ethics, and continuous improvement.
• Work closely with manufacturing operations to prevent issues and respond promptly to unexpected events.