Director, Quality Management Systems

3 weken geleden

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

Santen Inc is seeking a highly skilled and experienced Director, Quality Management Systems to lead our Quality Management Systems (QMS) function in the EMEA region.

Key Responsibilities
  • Develop and implement a robust QMS framework that ensures compliance with regulatory requirements and industry standards.
  • Lead the development and implementation of quality policies, procedures, and guidelines that align with Santen's global quality strategy.
  • Collaborate with cross-functional teams to ensure effective quality management and continuous improvement.
  • Develop and maintain a quality culture that promotes a customer-focused approach and a commitment to excellence.
  • Provide leadership and guidance to the QMS team to ensure effective implementation and maintenance of the QMS.
  • Develop and implement a risk management strategy that identifies, assesses, and mitigates quality risks.
  • Develop and implement a quality training program that ensures all employees have the necessary skills and knowledge to perform their jobs effectively.
  • Develop and maintain relationships with regulatory authorities and industry stakeholders to ensure compliance with regulatory requirements.
  • Develop and implement a quality metrics program that measures and tracks quality performance.
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 (e.g. TrackWise, Learning Management Systems...).
  • 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).
About Santen Inc

Santen Inc is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

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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