
Chief Quality Strategist
6 days ago
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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