Senior Director of Quality Systems

7 days ago

High Wycombe, Buckinghamshire, United Kingdom wax. Full time

We are seeking a highly experienced and dynamic Senior Director to lead our Global Quality Systems team at Wax, a patient-focused company dedicated to discovering, developing, and delivering high-quality medicines for rare metabolic diseases.

As a key member of our leadership team, you will play a vital role in supporting the mission, development, manufacturing, and supply of innovative products.

**Key Responsibilities:**

  1. Quality Management Systems Oversight: Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with international regulatory requirements.
  2. Computer System Quality Assurance: Ensure the integrity and compliance of computer systems in Good eXchange Practices (GxP) environments.
  3. Continuous Improvement: Promote and implement continuous improvement processes within the Quality team.
  4. Inspection Readiness: Lead preparations for regulatory inspections and audits, managing interactions with regulatory agencies.
  5. Global GxP Compliance: Maintain compliance with FDA, EMA, and other relevant regulatory bodies.
  6. 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.

**What You Bring:**

  • 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.

**Your Growth:**

  • 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.

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