Lead, Quality Management System

4 weken geleden


Amsterdam, Nederland Santen Voltijd
Job Description

JOB'S MISSION

  • Lead Santen EMEA Regional Quality Governance Activities to ensure that EMEA Quality Management System (QMS) processes are working properly and continuous improvement is achieved.
  • Lead EMEA Quality Audit Management. Roll out of consolidated supplier risk assessment and audit plan (CMO, API,GDP,ISO).  
  • Support EMEA Learning Management System activities including GxP/ISO Training.
  • 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 support 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 support quality operational tasks and cross-functional projects related EMEA Quality Management System (QMS) in connection with EMEA Director QMS and IT quality.


Qualifications

EDUCATION

Essential

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

Desirable

  • Project Management

EXPERIENCE

Essential

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

Desirable

  • Enhanced IT system skills
  • SAP


Additional Information

Functional Competencies

  • Strategic thinking
  • Analytical skill
  • Excellent communication skills including ability to present to senior management
  • Curiosity, Initiative, Passion for the business
  • Cross functional project management skills
  • Ability for problem identification and solving

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.



  • Amsterdam, Noord-Holland, Nederland Santen Voltijd

    Job DescriptionJOB'S MISSIONLead Santen EMEA Regional Quality Governance Activities to ensure that EMEA Quality Management System (QMS) processes are working properly and continuous improvement is achieved.Lead EMEA Quality Audit Management. Roll out of consolidated supplier risk assessment and audit plan (CMO, API,GDP,ISO). Support EMEA Learning Management...


  • Amsterdam, Noord-Holland, Nederland Santen Voltijd

    Company DescriptionAs a global specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen's long-term vision is to become a social innovator in ophthalmology and address social and economic...


  • Amsterdam, Nederland Santen Voltijd

    **Company Description** As a global specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen’s long-term vision is to become a social innovator in ophthalmology and address social and...

  • Data Quality Lead

    2 weken geleden


    Amsterdam, Nederland IMC Financial Markets Voltijd

    As lead of our Data Quality team, you will play a pivotal role in shaping the future of our systematic trading operations. This role offers an excellent opportunity for an ambitious and entrepreneurial mind that wants to build and grow a team that operates at the core of our trading operations. You will have the ability to play an active part in defining the...

  • Regional Quality

    4 dagen geleden


    Amsterdam, Nederland Boehringer Ingelheim B.V. Voltijd

    **WHO ARE WE?**: ROPU MIDI is a Regional Operating Unit consisting of 8 mid-sized European countries: Belgium, Denmark, Finland, Greece, Norway, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region. **THE...

  • Data Quality Lead

    4 weken geleden


    Amsterdam, Nederland IMC Voltijd

    As lead of our Data Quality team, you will play a pivotal role in shaping the future of our systematic trading operations. This role offers an excellent opportunity for an ambitious and entrepreneurial mind that wants to build and grow a team that operates at the core of our trading operations. You will have the ability to play an active part in defining the...

  • Data Quality Lead

    2 maanden geleden


    Amsterdam, Nederland IMC Voltijd

    As lead of our Data Quality team, you will play a pivotal role in shaping the future of our systematic trading operations. This role offers an excellent opportunity for an ambitious and entrepreneurial mind that wants to build and grow a team that operates at the core of our trading operations. You will have the ability to play an active part in defining the...

  • [EMEA] Director, QMS

    4 weken geleden


    Amsterdam, Nederland Santen Inc Voltijd

    [EMEA] Director, QMS & CS Quality Full-time 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...

  • [EMEA] Director, QMS

    4 weken geleden


    Amsterdam, Nederland Santen Inc Voltijd

    [EMEA] Director, QMS & CS Quality Full-time 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...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...


  • Amsterdam, Noord-Holland, Nederland Picnic Voltijd

    At Picnic, we're revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our operations,...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...


  • Amsterdam, Nederland Picnic Voltijd

    At Picnic, we’re revolutionizing the way people buy groceries providing high-quality, fresh products to our customers with our innovative and sustainable app-only service. We do almost everything in-house, developing cutting-edge technologies and processes to ensure we continue to grow rapidly without missing a beat. As we continue to expand our...

  • Team Lead Quality Assurance

    3 weken geleden


    Amsterdam, Nederland Artsen Zonder Grenzen Voltijd

    **Job Brief**: You are responsible for the performance of the organisation’s quality assurance, expert advice and support regarding quality assurance and the procurement of pharmaceuticals or medical devices or specialised food products by leading, **MSF is an international, independent medical humanitarian organization. We are a non-profit, self-governed...

  • Regional Quality

    1 week geleden


    Amsterdam, Noord-Holland, Nederland Boehringer Ingelheim B.V. Voltijd

    WHO ARE WE?:ROPU MIDI is a Regional Operating Unit consisting of 8 mid-sized European countries: Belgium, Denmark, Finland, Greece, Norway, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.THE...


  • Amsterdam, Nederland Covestic Inc Voltijd

    Milestone Technologies is currently hiring for an Asset Lifecycle Management Lead in Amsterdam. The Logistics Team Lead is responsible for managing the activities and responsibilities of their respective Logistics team. This includes inbound, outbound, deployment, and supply depot services at all offices. This leadership role is also responsible for...

  • Management IT Area Lead

    2 weken geleden


    Amsterdam, Nederland ING Voltijd

    Do you love problem solving and take pride in creating outstanding employee experiences? Are you an optimistic and compassionate person who thrives off helping others be successful? If yes, we are looking for you to join our team and help improve the products and services we offer to our employees. **Who we are** We are Global Digital Workplace & Employee...