Chief Quality Strategist

6 days ago


Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €150,000
Global Quality Director

As a senior leader in quality management, you will oversee the development and implementation of quality policies and procedures across worldwide manufacturing facilities. This involves managing a large organization, collaborating with stakeholders, and ensuring compliance with regulatory requirements.

Responsibilities:
  • Establishing and maintaining a culture of quality excellence
  • Managing a global team to drive quality initiatives
  • Collaborating with stakeholders to achieve business objectives
  • Ensuring compliance with regulatory requirements (FDA, ISO, ASQ, RAC)

Significant experience with FDA certification processes is required.

Requirements:
  • Strong leadership and interpersonal skills
  • Proficiency in Microsoft Office for data analysis and reporting
  • Understanding of validation principles and testing procedures
  • Knowledge of FDA, ISO, RAC, and CQA regulations and standards
  • Willingness to travel internationally (60%+)

Typical Experience: 10-12 years in quality management and related functions (Manufacturing Quality, Design Quality, Validation, Quality Assurance, Quality Systems). Minimum 5 years conducting quality audits. Experience with FDA and regulatory inspections. In-depth knowledge of quality management systems and global compliance. Experience in the HealthTech industry. Global and multi-site leadership experience. Experience in driving cultural change for quality awareness.



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