Santen

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's Mission

• To ensure that operational quality-related tasks associated with Good Distribution Practice (GDP) are performed for Santen SA/NL.
• To perform the operational quality-related tasks in SA/NL and EMEA. 
• To provide in-depth knowledge and support for Quality Systems (VQD / Trackwise / LM Success Factors)
• To participate on regional and global project teams as required.
• To compile data to support management / quality review meetings on a regular basis.
• To collaborate with business partners on assigned projects and tasks

Job Description

• To manage distribution deviations, investigations, CAPAs and changes together with Santen EMEA QAs 
• To investigate deviations associated with product distribution i.e Temperature excursions. 
• To handle quality incidents from service providers
• To support self-inspections at appropriate regular intervals following a prearranged program.
• To support the Santen SA/NL Responsible Person.
• To support the EMEA QA to ensure that initial and continuous training programs are implemented and maintained. 
• To maintain Quality agreements with Santen affiliates and external organizations 
• To compile data to support regular quality review meetings, following up KPIs, action items and CAPA plan implementation, managing change controls, and supporting on decisions related to deviations. 
• To provide support and training to SA/NL departments to manage TW records as Single Point of Contact from QA
• To support quality inspections from external parties.

Qualifications

• Bachelor’s or Master’s degree in life sciences, preferably pharmacy 
• Advanced quality management skills and GDP/ GMP knowledge
• 3 years experience in pharmaceutical industry in a Quality function, preferably related GDP 
• Participated in external GDP trainings
• Hands-on experience in Logistics and Experience as trainer is a big plus
• Open and transparent communicator 
• Analytic and investigative mindset 
• Teamworker 
• Sense for high urgency actions 
• Patient safety oriented
• Excellent or good command of spoken and written English; Good command of spoken and written Dutch is preferred.
• Collaboration beyond boundaries 
• Customer focused value creation
• Integrity & trust
• Drive for achievement 

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.

Santen SA, the Netherlands Branch has an exclusive arrangement for recruitment services. External recruiting agencies are kindly requested not to contact us regarding the positions listed here.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.