[GLOBAL] Director, Supplier Quality

In alignment with Santen vision and with Global Quality strategy, objectives, and directions:

• To act, within the Global Quality organization, as the first Santen Quality point of contact for all procured strategic materials (APIs, excipients, intermediates, packaging materials…), ensuring proper coordination of and input on any quality matter
• To ensure that appropriate capabilities as well as an efficient organization are in place at all times
• To ensure that the relevant quality expertise is developed and sustained across the organization, and effective quality support and guidance is provided at all times
• To lead and drive the quality management of all strategic suppliers, globally, during their entire lifecycle, ensuring:

1. The development of a robust supplier quality strategy and its translation into tactical plans, including optimal and standardized operational models between Santen and its global external network
2. An updated, consolidated and approved list of strategic suppliers, along with their characteristics and risk profile, is available at all times
3. Effective and efficient quality oversight of the global supplier network
4. Timely and successful resolution of any quality event so as to prevent recurrence
5. Appropriate and timely quality decisions are made and communicated to relevant stakeholders
6. Development and implementation of state-of-the start and standardized governance, procedures, processes, tools and ways of working, including quality reviews
7. Identification and effective implementation of continuous quality improvement plans
8. Effective follow-up on audit CAPAs, quality support and guidance
9. Appropriate metrics to monitor performance are defined, implemented and communicated
10. Appropriate identification, assessment, prevention and mitigation of risks
11. Development and implementation of quality agreements or other quality-related contractual documents
12. Proper selection, qualification or disqualification of suppliers
13. Effective quality management of supplier-related projects

• Where required, to:

1. Participate to, or lead external audits and due diligence visits
2. Act as the quality representative within projects in Santen Organization
3. Act as a deputy RP in Switzerland, fulfilling all duties and responsibilities according to current regulations
4. Actively participate to the Global Quality Operations Management Team, to lead cross-functional initiatives, and to proactively support other GQOMT members where needed
5. Lead, organize, manage, develop, and coach the team, fostering the right behaviors and mindset
6. Manage the allocated budget

• 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 10 years of team leadership experience in global, multicultural environments
• Significant knowledge and understanding of API manufacturing operations
• Strong knowledge and understanding of worldwide GMP/ ISO regulations related to APIs and other materials
• English: fluent, French: fluent
• Leadership
• Excellent co-operative skills in international business
• Excellent organizational and communication skills
• Strong project management skills
• Strong stakeholder management skills
• Agility, flexibility, ability to handle conflicting priorities and to solve problems
• Intercultural sensitivity and awareness, across Europe and Asia at a minimum
• Pragmatic, result-oriented, customer-focused. Able to translate a strategy into tactical plans and achievements.
• Advanced skills in TrackWise (QM), VeevaVault, SAP
• Negotiation

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.