Group QMS Manager

The Group Quality Management System Manager is responsible for developing, deploying and maintaining the Group Quality Management System across Unilabs Group in line with our aspiration, the promises we make and the needs of the markets we serve.

Responsibilities

• 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.
• Develop, maintain, improve standardized workflows within the digital QMS 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.

Leadership

• 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 individual point of view, listens carefully to extract business potentials.

• Master’s Degree in a technical/ process engineering/QA discipline, Advanced Degree preferred, with significant related professional experience within the healthcare environment.

• Experience in industries such as healthcare, clinical laboratories, pharmaceuticals, medical devices is preferred.

• Proven track record of implementing, maintaining, and improving QMS frameworks in compliance with international standards (e.g. ISO 9001, ISO 13485, ISO 15189, CAP, GMP, etc.).

• Demonstrated ability to affect change.

• English fluent as a must (presenting, writing, reading).  Minimum Years Recommended and/or Preferred: 8-10 years.