Quality Manager Design & Qualification (all genders) - limited until 30.06.2028 (Biopharma)

Location: Frankfurt am Main, Germany; onsite

Salary: €80,724–€107,620 per year

Company

hirify.global is developing a fully automated insulin drug substance facility in Frankfurt to support its insulin portfolio from development through delivery.

What you will do

• Oversee commissioning, qualification, and validation activities for facilities, critical utilities, equipment, and computerized systems.
• Develop and implement cGMP design, IFF quality concepts, and commissioning, qualification, and validation strategies with Engineering.
• Participate in project workstreams and provide expert guidance on quality processes, procedures, and compliance.
• Prepare and execute protocols, reports, validation master plans, and system impact assessments.
• Provide quality oversight for supplier qualification engineering, including FAT, SAT, vendor documentation, and test execution.
• Lead and mentor team members while promoting quality compliance and continuous improvement.

Requirements

• Advanced degree in Engineering, Science, Pharmacy, or an equivalent field; MSc or PhD preferred.
• 3–5 years of industry experience in biopharma or a related regulated industry.
• Proven experience in quality system management, the process validation lifecycle, and Quality by Design principles.
• Strong understanding of pharmaceutical manufacturing processes and GxP regulations.
• Expertise in quality systems, risk management, and continuous improvement methodologies.
• Experience with international regulatory bodies and FDA requirements.
• Strong leadership, communication, decision-making, negotiation, and mentoring skills.
• English proficiency is required.

Nice to have

• Knowledge of German or French.

Culture & Benefits

• Fixed-term full-time position through 30 June 2028.
• Work as part of a cross-functional global insulin program team from design and construction through commercial manufacturing readiness.
• Equal-opportunity workplace with a focus on diversity, equity, and inclusion.
• Employees may be eligible for company benefit programs.

Hiring process

• Apply only via the “Apply” button.
• Include a letter of motivation and a current resume.