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7 days ago
The Director of Quality System will lead and improve the company's global quality management system, vendor management systems, and computer system validation across the enterprise. This is a senior leadership role responsible for overseeing the design, implementation, and continuous improvement of the quality management system.
- Lead the global quality management system to ensure alignment with international regulatory requirements and industry best practices.
- Ensure compliance with GxP, ISO, and applicable regulatory requirements.
- Develop and implement strategies for the validation and lifecycle management of computerized systems.
- Champion data integrity and system security across all validated systems.
This is an excellent opportunity to join a rapidly expanding global healthcare services business. The company values entrepreneurial, innovative, and collaborative approaches, with a strong problem-solving ethos. Diversity is embraced as the business grows domestically and internationally.
Key Requirements- Bachelor's or Master's degree in Life Sciences, Pharmacy, IT, or Engineering, or related discipline.
- Minimum of 10 years' experience in pharmaceutical, medical device, or life sciences industries with at least 5 years in a computer system validation senior leadership role.
- Deep understanding of QMS frameworks, GxP compliance, and international regulatory requirements.
- Proven expertise in vendor management, supplier quality, and audit oversight.
- Strong experience in Computer System Validation (CSV) and computerized systems lifecycle management.
As a Director of Quality System, you will have the opportunity to work in a matrixed, multinational organization and lead cross-functional teams and manage complex global projects. Excellent leadership, communication, and stakeholder engagement skills are essential for this role.
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