Lead, Quality Management System

1 week geleden


Amsterdam, Noord-Holland, 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.



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