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, the position holder is accountable, within the EMEA region, for leading and driving Quality oversight of the following activities:

• Distribution operations – all allocated products
• Commercial affiliate operations – all allocated products
• NL-based functions

Depending on business needs and on the country of location, the position holder may also act as a NL RP (or deputy RP) and/or PRRC, or FR PRI.

For the allocated product portfolio, in alignment with Santen vision and with Global Quality strategy, objectives, and directions, and in compliance with any applicable requirements:

• To lead and drive Quality operations for EMEA distribution operations, ensuring:
o Effective and efficient organization to best support the company goals and vision
o Effective implementation of all applicable quality standards, policies and processes
o Development and implementation of robust, efficient, state-of-the art governance, procedures,
processes, systems, and tools across the EMEA distribution network
o Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
o Effective management of repackaging/reworking/labeling operations, QC importation testing or any other operation needed to support the business
o Identification and effective implementation of appropriate improvement plans
o Proper selection, qualification and quality oversight of third-party distributors and transporters
(quality agreements, quality reviews, performance monitoring, risk assessment, continuous
improvement, support to inspection, phase-out…)
o Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial
Operations entities so as to ensure timely and effective implementation of global processes
o Appropriate performance management

• To lead and drive Quality operations within the EMEA commercial network, ensuring:
o Effective and efficient organization to best support the company goals and vision
o Effective implementation of all applicable quality standards, policies and processes
o Development and implementation of robust, efficient, state-of-the art governance, procedures,
processes, systems, and tools across the commercial network
o All-time inspection readiness, including adequate regulatory inspection preparation, management,
and follow-up, and appropriate self-inspection program
o Effective communication within any local Health Authorities and the country/cluster organization,
making sure that any commitment will properly tracked and closed on time
o Effective liaison with EMEA Quality, Global Quality or other Product Supply / Commercial
Operations entities so as to ensure timely and effective implementation of global processes
o Appropriate performance management
o Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
o Identification and effective implementation of appropriate improvement plans
o Proper selection, qualification and quality oversight of third-party service providers (quality
agreements, quality reviews, performance monitoring, risk assessment, continuous improvement,
support to inspections, phase-out…)
o The right mindset is fostered across the network
o Appropriate quality support and training/education

• To lead quality oversight of NL-based EMEA functions, ensuring:
o Effective management of any operational quality matter, risk and opportunity, incl. quality reviews
and quality performance monitoring
o Effective implementation of all applicable quality standards, policies and processes
o Identification and effective implementation of appropriate improvement plans
o The right mindset is foster across those functions
o Appropriate quality support and training/education
• To ensure Santen SA/NL complies with its duties per any applicable license, incl. possible RP/PRRC role
• To represent EMEA Quality in global projects
• To actively participate to the EMEA Quality Leadership Team (QLT) and to lead cross-functional
initiatives, and to proactively support other QLT members where needed
• To lead, organize, manage, develop, and coach the team, fostering the right behaviors and mindset
• To manage the allocated budget

• M.Sc. education in pharmacy, chemistry, biology, or life science
• Lean Six Sigma Green Belt certification a bonus
• 12-15 years of Quality experience in pharma companies operating globally
• Minimum 5 years of experience in a multi-site or regional corporate quality role with a focus on distribution and country quality
• Thorough knowledge and understanding of any applicable GxP and Medical Device-related requirements and regulations
• Experience in successfully leading cross-functional teams and projects at multi-site or regional level
• Thorough understanding of distribution, and commercial activities
• Significant experience in managing regulatory inspections and interacting with authorities
• Significant experience in managing third-party organizations
• Strong knowledge of risk management approaches and methods
• Exposure to other products and their regulations such as food supplements
• Intercultural sensitivity and awareness
• Knowledge in the use of project management tools

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.

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