Director, Quality Management Systems

2 weken geleden

Amsterdam, Noord-Holland, Nederland Santen Inc Voltijd
Job Description

Santen Inc is seeking a highly skilled and experienced Quality Management Systems Director to lead our EMEA region. As a key member of our Quality Leadership Team, you will be responsible for driving the development and implementation of our Quality Management System (QMS) across the region.

Key Responsibilities
  • Develop and implement a robust QMS that ensures compliance with all applicable regulatory requirements.
  • Lead the development and implementation of quality policies, procedures, and guidelines.
  • Manage and coordinate audits, inspections, and other quality-related activities.
  • Develop and implement a risk management program to identify and mitigate potential quality risks.
  • Lead the development and implementation of a quality knowledge management program to ensure that all employees have access to the necessary information and training to perform their jobs effectively.
  • Develop and implement a quality intelligence program to monitor and analyze quality data and trends.
  • Represent the EMEA region on global quality projects and initiatives.
  • Lead and manage a team of quality professionals to ensure the effective implementation of the QMS.
Requirements
  • M.Sc. education in pharmacy, chemistry, biology, or life science.
  • 12-15 years of Quality experience in pharma companies operating globally (EMEA, USA, Asia).
  • Minimum 5 years of experience in a cross-functional (multi-site or regional) corporate quality role with a focus on quality systems and audits.
  • Thorough understanding of quality management system applied to manufacturing, distribution and commercial operations, and related digital tools.
  • Strong knowledge of pharmaceutical regulations (EU and US FDA as a minimum).
  • Experience in successfully leading cross-functional project at multi-site or regional level.
  • Extensive knowledge of ISO and worldwide GxP regulations.
  • Thorough understanding of aseptic manufacturing operations, distribution, and commercial activities.
  • Significant experience in managing regulatory inspections and interacting with authorities (EMA, FDA).
  • Strong knowledge of risk management approaches and methods.
Desirable
  • IT additional studies.
  • Strong knowledge of medical device regulation (MDR, ISO13485).
  • Exposure to other products and their regulations such as food supplements.
  • Intercultural sensitivity and awareness.
  • Knowledge in the use of project management tools.
  • Lean Six Sigma Green Belt certification.
  • Advanced skills in electronic quality management tools (Trackwise, Veeva Doc).

Santen Inc is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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