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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 play a vital role in ensuring the quality and compliance of our products and services.
Key Responsibilities
- Quality Management Systems Oversight: Develop, implement, and maintain a robust Quality Management System (QMS) that meets international regulatory requirements.
- Computer System Quality Assurance: Ensure the integrity and compliance of computer systems in GxP environments, ensuring seamless integration with our business operations.
- Continuous Improvement: Promote and implement continuous improvement processes within the Quality team, driving innovation and excellence in healthcare.
- Inspection Readiness: Lead preparations for regulatory inspections and audits, managing interactions with regulatory agencies to ensure compliance.
- Global GxP Compliance: Maintain compliance with FDA, EMA, and other relevant regulatory bodies, ensuring our products meet the highest standards of quality and safety.
- Cross-Functional Collaboration: Collaborate with various departments to ensure quality and compliance are integrated throughout the business, driving a culture of excellence.
Your Impact
- Lead and execute strategic quality initiatives, driving business growth and improvement.
- Drive a culture of quality and innovation across global operations, ensuring our products meet the highest standards of quality and safety.
- Enhance company-wide compliance with global quality and regulatory requirements, ensuring our business remains competitive and compliant.
About You
- Proven leadership in Quality Systems within the biotech or pharmaceutical industry, with a deep understanding of QMS, GxP environments, and regulatory compliance.
- A passion for driving innovation and excellence in healthcare, with a strong track record of delivering high-quality results.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams to drive business growth and improvement.
About wax
- We are a patient-focused company dedicated to discovering, developing, and delivering high-quality medicines for rare metabolic diseases.
- We are committed to making a difference in the lives of patients globally, and we are seeking a talented and experienced Senior Director to join our team.
- We offer a dynamic and supportive work environment, with opportunities for growth and professional development.
