Company Description
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.
Job Description
Are you passionate about driving excellence in pharmaceutical quality management? Join Santen, a global leader in ophthalmology, and take ownership of quality oversight for our strategic suppliers across the EMEA regions. We are looking for a Director, Supplier Quality to join our team in Amsterdam or Paris.(Hybrid)
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.
Qualifications
What you will bring to the role
- 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
Ready to make a difference?
Apply today and help us shape the future of eye health.
Additional Information
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
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.
If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.
