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Head of Global Quality Management
2 months ago
We are seeking a highly experienced and skilled Senior Director to lead our Global Quality Systems team at wax., a leading biotechnology company dedicated to discovering, developing, and delivering high-quality medicines for rare metabolic diseases.
As the Senior Director, you will be responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) in compliance with international regulatory requirements.
Key Responsibilities:
- Computer System Quality Assurance: Ensure the integrity and compliance of computer systems in GxP environments.
- Promote and Implement Continuous Improvement: Drive continuous improvement processes within the Quality team to enhance efficiency and effectiveness.
- 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.
Requirements:
- Proven leadership in Quality Systems within the biotech or pharmaceutical industry.
- Deep knowledge of QMS, GxP environments, and regulatory compliance.
- Strong communication and interpersonal skills.
This is an exciting opportunity to lead in a challenging and rewarding role, contributing to ground-breaking work in the biotech industry.
