Quality Director

BioSystems; Barcelona; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Innovative work environment

Job summary

BioSystems, a global leader in analytical solutions for IVD and life sciences, is seeking a Quality Director to lead the Quality and Regulatory Affairs function. You will shape strategy and drive robust quality programs across the organization, aligning with regulatory requirements and business goals.

You will manage QA, RA, QC and Analytical Evaluation teams, oversee the QMS, audits, regulatory submissions, and external interactions, mentoring leaders to foster a culture of excellence worldwide.

Qualifications

• Minimum 10 years of Quality/Regulatory Affairs experience in IVD or Life Sciences.
• Strong knowledge of IVDR, ISO 13485, CE Marking and QMS.
• Strategic, hands-on leader with excellent communication and stakeholder management.

Responsibilities

• Define and implement Quality and Regulatory strategy aligned with company objectives.
• Ensure compliance with regulatory requirements and quality standards across global markets.
• Lead the Quality Assurance, Regulatory Affairs, Quality Control, and Analytical Evaluation teams.
• Oversee the Quality Management System, audits, inspections, certifications, regulatory submissions, and external interactions.
• Support product development and lifecycle activities with regulatory and quality input.
• Drive a culture of quality, compliance, accountability, and continuous improvement.
• Monitor regulatory developments and market trends to identify risks and opportunities.
• Partner with cross-functional teams to support innovation and business growth.

Skills

Strategic Leadership

Team Development

Critical Thinking

Change & Transformation Management

Stakeholder Engagement

Education

Degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, Biomedical Sciences, or related field

Job description

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
• 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.

Key Skills

• Strategic Leadership
• Team Development & Coaching
• Critical Thinking & Decision-MakingChange & Transformation Management
• Stakeholder Engagement

What We Offer

An innovative work environment that fosters collaboration, engagement, and professional growth