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Senior Director, Head of Global Quality Management Systems
2 months ago
Job Overview
We are seeking a highly experienced and skilled Senior Director to lead our Global Quality Systems team at Wax, a globally recognized patient-focused company dedicated to discovering, developing, and delivering high-quality medicines for rare metabolic diseases.
About the Role
- Lead Global Quality Systems: Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with international regulatory requirements.
- Computer System Quality Assurance: Ensure the integrity and compliance of computer systems in GxP environments.
- Continuous Improvement: Promote and implement continuous improvement processes within the Quality team.
- Inspection Readiness: Lead preparations for regulatory inspections and audits, managing interactions with regulatory agencies.
- Global GxP Compliance: Maintain compliance with FDA, EMA, and other relevant regulatory bodies.
- Cross-Functional Collaboration: Collaborate with various departments to ensure quality and compliance are integrated throughout the business.
Your Impact
- Lead and execute strategic quality initiatives.
- Drive a culture of quality and innovation across global operations.
- Enhance company-wide compliance with global quality and regulatory requirements.
Requirements
- Proven leadership in Quality Systems within the biotech or pharmaceutical industry.
- Deep knowledge of QMS, GxP environments, and regulatory compliance.
- A passion for driving innovation and excellence in healthcare.
About Wax
- We are a mission-driven organization committed to making a difference in the lives of patients with rare diseases.
- We collaborate with a diverse and expert team to deliver high-quality medicines.
- We are dedicated to continuous improvement and innovation in the biotech industry.
