
Director, Supplier Quality EMEA
- Amsterdam, Noord-Holland
- Vast
- Voltijds
In this pivotal role, you will be the go-to expert for all quality-related matters and you will ensure compliance with internal standards and external regulations (GxP, ISO, etc.), whilst building strong partnerships with suppliers to uphold the highest quality standards.What you will do
- Act as the primary Quality point of contact within the Global Quality organization for all strategic materials (APIs, excipients, intermediates, packaging).
- Ensure the Quality function is equipped with the right capabilities, structure, and expertise to support business needs.
- Foster a culture of continuous improvement and quality excellence across the organization.
- Lead and drive the quality management of all allocated strategic suppliers, during their entire lifecycle, ensuring:
- The development of a robust supplier quality strategy and its translation into tactical plans, including optimal and standardized operational models between Santen and its network of suppliers
- An updated, consolidated and approved list of strategic suppliers, along with their characteristics and risk profile, is available at all times
- Effective and efficient quality oversight of the global supplier network
- Timely and successful resolution of any quality event to prevent recurrence
- Appropriate and timely quality decisions are made and communicated to relevant stakeholders
- Development and implementation of state-of-the start and standardized governance, procedures, processes, tools and ways of working, including quality reviews
- Identification and effective implementation of continuous quality improvement plans
- Effective follow-up on audit CAPAs, quality support and guidance
- Appropriate metrics to monitor performance are defined, implemented and communicated
- Appropriate identification, assessment, prevention and mitigation of risks
- Development and implementation of quality agreements or other quality-related contractual documents
- Proper selection, qualification or disqualification of suppliers
- Effective quality management of supplier-related projects
- Actively contribute to the EMEA Quality Leadership Team and lead cross-functional initiatives.
- Collaborate with other QLT members to support strategic quality goals.
- Lead, coach, and develop your team, fostering a mindset of accountability, agility, and excellence.
- M.Sc or B.Sc in biology, pharmacy, chemistry, engineering or relevant area
- 15-20 years of experience within the healthcare industry, in manufacturing and quality operational positions of growing responsibility
- Significant experience in managing external operations / suppliers, across multiple countries and for a wide range of products
- Minimum of 5 years of team leadership experience in global, multicultural environments
- Significant knowledge and understanding of API manufacturing operations