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.
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.
- 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.