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Director of Quality Management
2 maanden geleden
Director, Quality Management Systems & Compliance
Santen Inc is seeking a highly skilled and experienced Director to lead our Quality Management Systems and Compliance efforts in the EMEA region.
Key Responsibilities:
- Develop and implement effective quality management systems to ensure compliance with regulatory requirements and industry standards.
- Lead cross-functional teams to drive quality initiatives and improve processes.
- Collaborate with stakeholders to identify and mitigate risks, and develop strategies to address quality-related issues.
- Provide guidance and support to ensure compliance with regulatory requirements and industry standards.
- Develop and maintain quality policies, procedures, and guidelines.
- Lead audits and inspections to ensure compliance with regulatory requirements and industry standards.
- Develop and implement training programs to ensure quality awareness and compliance.
- Monitor and report on quality metrics and performance indicators.
Requirements:
- Master's degree in a relevant field (e.g. 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 corporate quality role with a focus on quality systems and audits.
- Thorough understanding of quality management systems applied to manufacturing, distribution, and commercial operations.
- 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.
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. 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:
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.
