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Director, Quality Management Systems
2 maanden geleden
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 that ensures compliance with regulatory requirements and industry standards.
- Lead the development and implementation of quality policies, procedures, and guidelines.
- Manage and maintain the QMS, including performance monitoring, audit and regulatory inspection management, and risk management.
- Collaborate with cross-functional teams to ensure effective quality governance and knowledge management.
- Develop and implement quality assurance activities for computerized systems, including validation and compliance.
- Lead and drive quality business continuity planning and risk management activities.
- Represent EMEA Quality in global projects related to quality management systems.
- 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.
- 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.
