Director of Quality Management Systems
1 week geleden
About the Role:
We are seeking a highly experienced and skilled Director to lead our Quality Management Systems (QMS) and Computerized Systems (CS) Quality functions in the EMEA region. As a key member of our Quality Leadership Team, you will be responsible for driving the development and implementation of our QMS and CS Quality strategies, ensuring compliance with regulatory requirements and industry best practices.
Key Responsibilities:
- Develop and implement QMS and CS Quality strategies to ensure compliance with regulatory requirements and industry best practices.
- Lead the development and implementation of quality policies, procedures, and guidelines.
- Manage and coordinate audits, inspections, and other quality-related activities.
- Develop and implement risk management strategies to mitigate quality risks.
- Lead the development and implementation of quality training programs.
- Collaborate with cross-functional teams to ensure quality is integrated into all aspects of our business.
- Develop and manage budgets and resources to support QMS and CS Quality functions.
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 systems 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 projects 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:
Santen 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.
Equal Opportunity Employer:
The Santen Group 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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