R&D Quality & Compliance Officer
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.
- 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…
Bachelor’s degree in a business / healthcare administration or equivalent experience in a related field, with multilingual qualifications or proven experience.
A minimum of 5 years in coordinating role, preferably in an international environment.
- 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