Your mission
We are searching for a Quality Systems Specialist (m/f/d) to support the establishment and management of an innovative pharmaceutical Quality Management System (QMS).
Key Responsibilities:
Reporting to the Senior Director of Quality, you will:
Key Responsibilities:
Reporting to the Senior Director of Quality, you will:
- Coordinate and manage the daily operation of the QMS in compliance with GxP, regulatory, and internal standards.
- Implement and manage a system of QMS metrics and measures
- Serve as the principal point of contact for all QMS-related matters.
- Support the development, implementation, and continuous improvement of the QMS, ensuring alignment with applicable regulations.
- Oversee and coordinate core quality processes, including Document & Training Management, Supplier & Audit Management, Change Controls, Deviations, CAPAs, Self-Inspections, Complaints, and Risk Management.
- Apply a risk-based approach and maintain the Quality Risk Register.
- Prepare, review, and maintain quality policies, SOPs, and related documentation.
- Support the rollout and training of the QMS and the implementation of an eQMS (including system administration).
- Conduct self-inspections and ensure continuous improvement initiatives are embedded.
- Support and foster a strong Quality Culture:
- Provide cross-functional quality support in the design and implementation of processes as part of the QMS
- Deliver training and guidance on quality topics.
- Support quality investigations and Quality Management Reviews.
- Represent Quality in projects impacting the QMS.