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Senior Director of Quality Systems
2 months ago
We are seeking a highly experienced and dynamic Senior Director to lead our Global Quality Systems team. As a key member of our organization, you will play a vital role in supporting the mission, development, manufacturing, and supply of innovative products.
Key Responsibilities:- QMS Oversight: 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.
- 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.
- 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.
- Opportunity to lead a team of dedicated professionals.
- Make a significant contribution to a global healthcare mission.
- Grow professionally in a supportive and dynamic environment.
- Be part of a mission-driven organization committed to making a difference.
- Collaborate with a diverse and expert team.
- Impact the lives of patients globally with rare diseases.
