Quality System Manager
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Responsible for developing, implementing and maintaining the Pharmaceutical Quality Management System (QMS) to ensure compliance, continuous improvement and consistent performance across the global organisation.
Key Responsibilities:
- Manage the global QMS and support local QMS as required.
Manage core QMS processes including:
- Documentation
- Deviations
- CAPAs
- Change Control
Deliver related QMS training, including:
- Document Change Control
- Deviations
- CAPAs
- Ensure QMS inspection readiness.
- Interface with affiliates, auditors and inspectors.
- Manage audits and inspections from a QMS perspective as required.
- Own QMS KPIs and monitor QMS performance and continuous improvement.
- Read and analyse KPIs.
- Manage processes in alignment with a risk-based approach, including risk identification and escalation.
- Act as a key contributor to organisational maturity.
Experience Required:
- 10+ years of GxP experience.
- Minimum 5 years in a QMS-related managerial role.
- Good understanding of global organisations.
- Ideally, experience within large companies.
Systems:
The organisation currently uses Ennov as its eQMS.
Additional Information:
- If transitioning into a permanent position, people-management experience is essential.
- For a dedicated consultant, management of the QMS is required.
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