R&D Quality & Compliance Officer

Job description

Ref: MEC 244

 

The R&D Quality & Compliance Officer will act as the “Quality Management System (QMS) System Expert” and will be responsible for managing the day-to-day support activities for the global R&D Quality & Compliance group, with an extensive focus on managing and maintaining the QMS.

As an R&D Quality & Compliance Officer, you will be responsible for:

QMS Procedural Document (ProcDoc) Management:

  • Maintain the QMS ProcDoc module for global R&D (i.e. create main document sets, ensure templates are populated using correct styles, activate and supervise workflow status, create necessary reports to adequately follow up ProcDoc statuses)

QMS Learning Management System:

  • Maintain the QMS LMS module for global R&D (i.e. role based, training session management, run pre-defined metrics reports on training attendance rate, …)
  • Guide & support local training coordinators in managing individual training sessions

QMS Audit / CAPA Management:

  • Maintain the QMS Auditing module (current audit findings database) to run pre-defined metrics reports on audit observations and CAPAs for global R&D. 
  • Generate metrics supporting the quarterly board reporting activities
  • Populate the GLPG Document Management System with the Audit Certificates where appropriate
  • Populate CAPA components in QMS Auditing Module and ensure proper filing of audit / CAPA documentation. 

Administrative tasks:

  • Manage daily support to R&D Quality & Compliance group: agenda management, travel coordination, expense notes, etc…
  • Coordinate Records Retention activities by supporting the R&D business partners in view of off-site archiving activities, records clean-out activities, etc…

 

Requirements

Education

Bachelor’s degree in a business / healthcare administration or equivalent experience in a related field, with multilingual qualifications or proven experience.

 

Experience

A minimum of 5 years in coordinating role, preferably in an international environment.

 

General Skills

  • Quality minded
  • Precise and accurate
  • System minded
  • Excellent MS Office skills (MS Word, Excel, Powerpoint, …)
  • Strong SharePoint knowledge
  • Strong organization skills
  • High degree of flexibility
  • Assertiveness and excellent communication skills
  • Analytical thinking
  • Problem solving