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Quality Management System (QMS) Consultant

Quality Management System (QMS) Consultant

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Quality Management System (QMS) Consultant

  • Location:


  • Sector:

    Quality Assurance & Validation - Pharma

  • Contact:

    Harry Reeve

  • Salary:

    €500 - €680 per day

  • Job type:


  • Contact email:

  • Job ref:


  • Published:

    19 days ago

  • Duration:

    6 Months

  • Startdate:


Job Summary:
The GxP/GMP/GDP QMS Consultant, reporting to the Head GxP Quality Management Systems, is responsible for supporting the development, implementation, and maintenance of a robust Quality Management System (QMS) framework for GMP/GDP quality processes and transversal (multi-GxP) processes. This role involves collaborating with stakeholders across GMP/GDP functions to ensure compliance with regulatory standards, identify and mitigate risks, and drive continuous improvement of the QMS.

Major Responsibilities:

Quality Management System:

  • Execute the GMP/GDP Corporate Quality System strategy aligned with the Patient Value Strategy.
  • Escalate QMS-related issues to the QMS Governance Body and collaborate on actions.
  • Act as a point of contact for GMP/GDP QMS questions and process improvement initiatives.
  • Assist in leading GMP/GDP QMS Governance and assess continuous improvement efforts.
  • Ensure alignment of QMS principles across functional areas by engaging with stakeholders.
  • Lead/participate in QMS@UCB Workstreams and facilitate QMS-related communication.
  • Support the execution of GxP QMS activities and provide regulatory interpretation.

Management Review:

  • Conduct Quality System Management Review and provide support during the process.


  • Lead GxP annual refresher training development and deployment.
  • Collaborate on designing and delivering QMS-related training.

QMS Documentation Framework:

  • Maintain oversight of GMP/GDP QMS E2E Documentation Architecture.
  • Support Gap Assessments (GA) in functional areas and coordinate translations.
  • Keep Entities informed about QMS documentation changes.

Audits and Inspections:

  • Provide inspection support for health authority inspections and customer audits.
  • Prepare sites for regulatory inspections in collaboration with QA teams.

Education & Qualification:

  • Bachelor's Degree required.


  • In-depth knowledge of Quality Systems, GMP/GDP, and regulatory standards.
  • Understanding of data integrity, risk management, and global regulatory requirements.
  • Strong communication, presentation, and interpersonal skills.
  • Fluent in English.
  • Independent worker with excellent teamwork and influencing abilities.
  • Proficient in risk analysis and issue resolution.
  • Strong analytical and investigative skills.
  • Effective planning and organizational skills.
  • Ability to build partnerships and manage projects.