Quality Director

BioSystems designs, develops, manufactures, and commercializes analytical solutions, including both reagent tests and analytical instrumentation for in vitro diagnostics (IVD) laboratories, as well as industrial applications. Our purpose is to improve health and well-being worldwide. To achieve this, we develop solutions based on the One Health concept, addressing:
• Human Health
• Animal Health
• Food Health
• Environmental Health
• Bioprocesses We are a global company operating in more than 100 markets through an extensive distributor network and with subsidiaries in 17 countries. This international presence allows us to stay close to the users of our products, provide outstanding customer support, and ensure technical assistance reaches customers around the world. We are looking for a Quality Director to lead the Quality and Regulatory Affairs function, ensuring compliance, operational excellence, and continuous improvement across the organization. This role will play a critical part in supporting business growth, product development, and international expansion within a highly regulated environment. Responsibilities
• Define and implement the Quality and Regulatory strategy aligned with company objectives.
• Ensure compliance with applicable regulatory requirements and quality standards across global markets.
• Lead and develop the Quality Assurance, Regulatory Affairs, Quality Control, and Analytical Evaluation teams.
• Oversee the Quality Management System, audits, inspections, certifications, regulatory submissions, and interactions with external authorities and notified bodies.
• Support product development and lifecycle activities, ensuring regulatory and quality requirements are effectively integrated.
• Drive a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
• Monitor regulatory developments, industry trends, and market dynamics to identify risks and opportunities.
• Partner closely with cross-functional teams to support innovation, operational excellence, and business growth. Requirements
• Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, Biomedical Sciences, or a related field.
• Minimum 10 years of experience in Quality and/or Regulatory Affairs within the IVD, Diagnostics, Medical Device, Biotechnology, or Life Sciences industry.
• Strong knowledge of IVDR, ISO 13485, CE Marking requirements, and quality management systems.
• Strategic mindset combined with a pragmatic and hands-on approach.
• Excellent leadership, stakeholder management, and communication skills.
• Fluent English. Key Skills
• Strategic Leadership
• Team Development & Coaching
• Critical Thinking & Decision-Making
• Change & Transformation Management
• Stakeholder Engagement
• Continuous Improvement Mindset

What We Offer
⏰ Flexible

working hours
39-hour workweek 🏡

Location:
Barcelona 🏃 Start date: Immediate availability preferred ☀️ An innovative work environment that fosters collaboration, engagement, and professional growth 🌱 Permanent employment contract