[global] Director, Supplier Quality

**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.**

**PURPOSE OF ROLE**
- In compliance with any internal and external (GxP, ISO ) applicable requirements, this position is accountable for leading and driving the quality management of all Santen strategic suppliers (APIs, intermediates, excipients, packaging materials ), globally.
- The position is therefore the first Santen point of contact for all quality matters in relation to procured strategic materials, worldwide.
- The position holder may also act as a deputy Responsible Person for Switzerland.

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:

- 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
- 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 so as 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
- Where required, to:

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

**Qualifications**
- 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

**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 v