Senior Director, Quality (Biotech)

Location: Waltham, Massachusetts, USA, or Breda, Netherlands

Salary: $191,250–$260,000 base salary annually in the United States, plus eligibility for variable cash compensation and, for eligible roles, equity.

Company

hirify.global develops technologies and solutions for bioprocessing and the production of biologic drugs.

What you will do

• Lead quality strategy across the global Filtration & System networks.
• Oversee Quality Assurance, Quality Systems, Quality Compliance, Validation, Quality Control, Supplier Quality, and Customer Quality activities.
• Ensure compliance with company policies, ISO requirements, applicable regulations, and customer expectations across multiple sites.
• Lead customer and certification audits, regulatory-agency interactions, investigations, and compliance initiatives.
• Develop, harmonize, and continuously improve quality systems, processes, procedures, and performance metrics.
• Build and mentor a high-performing quality organization while partnering with Operations, Commercial, Product Management, Supply Chain, Regulatory Affairs, and senior leadership.

Requirements

• Bachelor’s degree in science, engineering, quality, life sciences, or a related field; an advanced degree is preferred.
• 15+ years of quality leadership experience in bioprocessing, biotechnology, pharmaceuticals, medical devices, or regulated manufacturing.
• 5+ years leading a quality organization and 7+ years of people leadership experience.
• Experience executing quality strategies across multiple sites, functions, or global operations.
• Strong experience with customer audits, certification audits, regulatory authorities, and ISO 9001 requirements.
• Excellent leadership, communication, stakeholder management, analytical, and problem-solving skills.

Nice to have

• Experience with ISO 13485 quality management systems.
• Experience with sterilization, sterility assurance programs, and GMP.
• Experience in Filtration, Systems, bioprocessing, or related life sciences technologies.

Culture & Benefits

• Purpose-driven work supporting technologies for biologic drugs and human health.
• Collaborative environment focused on quality excellence, accountability, risk management, and continuous improvement.
• Paid time off and health, dental, and vision benefits.
• Retirement benefits and flexible spending accounts.
• Eligibility for variable cash programs and, where applicable, equity compensation.