Quality System Manager

Purpose

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:

• Root Cause Analysis
• 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.