Expert Quality Operations (Biotech)

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

Company

hirify.global develops and manufactures biopharmaceutical products, including monoclonal antibodies.

What you will do

• Provide day-to-day QA oversight for USP and DSP manufacturing, washing areas, and media and buffer preparation.
• Represent QA in manufacturing meetings and provide guidance on cGMP compliance, documentation, materials management, and SOP approval.
• Review and approve batch records, manufacturing deviations, investigations, CAPA plans, change controls, and risk assessments.
• Lead exception management and monitor preventive and corrective actions for timely, accurate resolution.
• Support inspection readiness and represent QA during health authority inspections.
• Train manufacturing personnel and act as backup for the QA Operations Supervisor.

Requirements

• At least 5 years of Quality Operations experience at pharmaceutical manufacturing sites.
• Thorough knowledge of cGMP and international regulatory requirements.
• Understanding of biotech manufacturing processes and experience with inspections.
• Degree or equivalent experience in natural or applied sciences, such as pharmacy, chemistry, biotechnology, or engineering.
• Strong analytical, problem-solving, verbal, and written communication skills, with a compliance-focused approach.
• French proficiency is preferred as the company language; English proficiency is preferred but not mandatory.

Nice to have

• Auditor qualification.

Culture & Benefits

• Focus on business integrity, ethics, regulatory compliance, and safety.
• Emphasis on continuous improvement and right-first-time manufacturing operations.
• Close collaboration between QA, manufacturing, and other Bioplant functions.