Group Quality Management System Manager

• Participate to the development and deployment of a strong Quality Culture from the company’s executive management to the rest of the organization.

• Drive the standardization and harmonization of quality management system and post-market processes for all business units of the group. Facilitates the design and validation of efficient workflow processes, conducts quality-related meetings, and develops documents (process maps/tables, procedures and forms) to guide the activities of the quality management processes.

• Coordinate the definition, monitoring, reporting and assessment of performance-related information for all sites and business units.

• Lead projects that impact the Quality Management strategy or the organizational structure, being responsible for the implementation of the projects within the given framework (time, budget, quality) and manage the projects through Key Performance Indicators.
• Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business.

• Ensure that quality related incidents are investigated and followed up in a systematic way across all geographies. Assists in root cause analysis and corrective action efforts, when needed.

• Drive the implementation of digital solutions with respect to quality related processes and other operational processes that impact customer satisfaction and / or the overall compliance level of the Group.

• Highlight potential threats and opportunities for quality through systematic risk assessment.

• Conduct or coordinate internal audits, oversee the delivery of these audits, generate audit reports including findings, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up.

• Represent Quality in the due diligence assessment done as part of the M&A Process and in the integration process for newly acquired companies.

• Facilitate the communication and sharing of best practices and good examples.

• Sets the overall direction for the standardization and harmonization of quality related processes considering the Group quality strategy and the big picture of internal and external aspects.

• Identifies and drives changes in a future-oriented, solution-oriented and proactive manner.

• Creates an open-minded atmosphere to allow innovative thinking by encouraging others to express their individualpoint of view, listens carefully to extract business potentials.

• Reporting line: Head Quality and Regulatory Affairs
• Part of the Group Operations Organization
• Location: Barcelona
• Full time position
• Travelling within the region (~20%)

• Solid interpersonal skills and relationship management
• Ability to influence and guide others at all levels of management
• Outgoing and dynamic. Comfortable working in a flat non-hierarchical environment
• Rigorous, organized, autonomous
• Ability to work independently and initiate contacts as necessary
• Excellent problem solving, risk analysis and negotiation skills
• Able to work effectively under pressure

• Master’s Degree in a technical/ process engineering/QA discipline, Advanced Degree preferred, with significant related professional experience within the healthcare environment
• Fully versed in ISO 13485, ISO 14971 and ISO 9001
• Experience with medical device regulation and/or in-vitro diagnostic directive regulation
• Demonstrated in-depth knowledge in quality process mapping and development
• Demonstrated ability to affect change
• English fluent as a must (presenting, writing, reading)
• Minimum Years Recommended and/or Preferred: 8-10 years

Unilabs