[The Netherlands] Senior Manager, Quality Management System

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. 

Santen is currently looking for a Senior Manager, Quality Management Systems to join their team in the Netherlands.

Job Description

What you will do

As a Sr. Manager QMS you will build Santen EMEA Regional Quality Governance Structure to ensure that EMEA Quality Management System (QMS) processes are working properly, and continuous improvement is achieved. Make sure that adequate KPIs are set to monitor Quality Systems health.

Furthermore, you will also be responsible for;

• Leading EMEA Quality Audit Management. Roll out of the consolidated supplier risk assessment and audit plan (CMO, API,GDP,ISO).
• Deploy new Risk Management across the EMEA QA Functions and drive risk mitigations activities.
• Establish EMEA Learning Management System Training Matrix covering GxP/ISO.
• Play key role in quality management system related activities to ensure continuous compliance of Santen EMEA to applicable EU pharma, distribution and medical devices regulations (EU GDP, MDD/MDR, ISO13485)

In alignment with Santen vision and with EMEA Quality strategy, objectives and directions, and in compliance with any external or internal regulatory requirements:

• To lead and manage activities and projects related to the development, standardization, implementation, monitoring and continuous improvement of the EMEA Quality management system ensuring:
  •  - Robust best-in-class, standardized policies, procedures, guidelines and models.
  •  - Effective and efficient roll-out and monitoring across all EMEA entities.
• To manage consolidated EMEA Quality Audit Plan to achieve:
  • Health Authority Inspection Readiness in EMEA
  • Qualified EMEA Auditor Pool
• To deploy new Risk Management Process across EMEA QA Functions and optimize the risk register by consolidation.
• To design GxP Training Matrix for the quality systems under the responsibility.
• To support quality operational tasks and cross-functional projects related EMEA Quality Management System (QMS) in connection with EMEA Director QMS and IT quality.
• To be the back up of SAP Quality Module Key User for EMEA

Qualifications

What you will bring to the role

• BSc or M.Sc in chemistry, pharmaceutical, biotechnology, or life science area
• 5+ year experience of working in Pharmaceutical, Medical Device industry or related area
• GxP experience and Quality Management System (QMS) knowledge
• Project Management & Quality Risk Management
• Root Cause Analysis
• e-QMS tools: Veeva, Trackwise
• SAP, SAP Quality Module, SAP Validation
• Power BI
• GxP Auditing
• Risk Assessment Experience in GxP Environment
• Fluent English written and spoken
• Knowledge and experience of quality management systems (QMS)

Additional Information

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.

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.