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Senior Director of Quality Systems
2 months ago
About the Role:
We are seeking a highly experienced and skilled Senior Director to lead our Global Quality Systems team at wax. As a key member of our organization, you will be responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) that meets international regulatory requirements.
Key Responsibilities:
- Develop and implement a QMS that ensures compliance with FDA, EMA, and other relevant regulatory bodies.
- Lead the Global Quality Systems team in ensuring the integrity and compliance of computer systems in GxP environments.
- Promote and implement continuous improvement processes within the Quality team.
- Lead preparations for regulatory inspections and audits, managing interactions with regulatory agencies.
- Maintain compliance with global quality and regulatory requirements.
- Collaborate with various departments to ensure quality and compliance are integrated throughout the business.
- 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.
About wax:
wax is a globally recognized company dedicated to discovering, developing, and delivering high-quality medicines for rare metabolic diseases. We are committed to making a positive impact on the lives of patients and their families.