[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. 

Job Description

* please only apply if you are located in Netherlands*

JOB'S MISSION

• 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.
• Lead 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)

KEY RESPONSIBILITIES & ACCOUNTABILITIES

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

EXPERIENCE

Essential

• Use of Microsoft office tools
• 5+ year experience of working in Pharmaceutical, Medical Device industry or related area
• e-QMS tools: Veeva, Trackwise

Desirable

• Enhanced IT system skills
• SAP, SAP Quality Module, SAP Validation
• Power BI
• GxP Auditing
• Risk Assessment Experience in GxP Environment

FUNCTIONAL COMPETENCIES

Essential

• Organizational skills: Ability to plan and structure tasks/activities
• Ability to communicate in a concise way,
• Teamworker
• Attention to details
• Flexibility
• Analytical mindset
• Problem solving
• Fluent English written and spoken

Desirable

• Knowledge and experience of quality management systems (QMS)

SANTEN LEADERSHIP COMPETENCIES

Essential

• Customer-focused value creation
• Expertise application
• Collaboration beyond boundaries
• Integrity and trust

Desirable

• NA

Qualifications

Essential

• BSc or M.Sc in chemistry, pharmaceutical, biotechnology, or life science area
• GxP experience and Quality Management System (QMS) knowledge

Desirable

• Project Management
• Quality Risk Management
• Root Cause Analysis

Additional Information

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.