[The Netherlands] QMS Specialist EMEA

Posted 6 Hours Ago
Be an Early Applicant
Amsterdam
Junior
Healthtech • Pharmaceutical
The Role
The QMS Specialist EMEA will manage electronic Quality Management Systems, oversee documentation, provide training on Veeva and Trackwise, and support the training process management to enhance quality assurance within the organization.
Summary Generated by Built In

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.

Are you ready to take your career to the next level and make a meaningful impact in the healthcare industry? We are seeking a talented and dynamic individual to join our team as a Manager, Market Access for the Iberia region. This is a pivotal role where you will drive the strategic market access efforts for our products and contribute to our mission of improving patient lives.

Job Description

We are looking for a System Administrator / Key User / Trainer for Santen EMEA QA organization for key electronic Quality Management Systems with at least one year experience in the pharmaceutical industry and with practical knowledge of eQMS Systems (Veeva / Trackwise / SF-LMS/ SAP QM).


Key Responsibilities & Accountabilities

  • Documentation Management (Veeva Quality Docs):
    • VQD Business Administrator
    • System Key User and account management
    • Trainer of VQD System and setting new user instructions
    • Member of the VQD Workflow Controllers team
    • Document hierarchy management
    • Document workflow controller and life cycle management
    • Read & Understand training assignments
    • Regular reporting of KPI’s related to VQD.


  • Quality Management (TrackWise):
    • System Key User / Trainer.
    • Member of the Global Trackwise Key User team
    • Account Management and reporting


  • Training management (Success Factors, Veeva - Learning Management System):
    • System Key User for LMS tools.


  • Training Process Management:
    • Support line managers, and training process owner, with training related to eQMS.
    • Organizing and performing F2F/on-line trainings
    • Maintenance of training matrices related to eQMS systems.
    • Reporting and follow-up of training completion


    Qualifications

    Essential

    • HBO / Batchelor’s / Master degree in life sciences.
    • Fluency in spoken and written English

    Desirable

    • Project management

    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 being 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.

    Top Skills

    Sap Qm
    Sf-Lms
    Trackwise
    Veeva
    The Company
    Goleta, California
    1,218 Employees
    On-site Workplace

    What We Do

    As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society.

    Santen Pharmaceutical Official Social Media Global Terms of Use​
    https://www.santen.com/en/legal

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