Head of Quality Systems
Vor 4 Tagen
**Quality Systems Leadership Opportunity at Lonza**
At Lonza, we are seeking a seasoned Quality Systems professional to lead our Quality Systems and Compliance organization. If you have a passion for quality and a drive to deliver excellence, this may be the perfect opportunity for you.
The selected candidate will be responsible for implementing quality systems capabilities that align with Lonza's quality strategy and supporting the success of assigned investment projects. Key responsibilities will include establishing a team of Quality Systems & Compliance managers/specialists, providing leadership to the team, and ensuring that quality and compliance goals are achieved.
**Key Responsibilities:**
- Establish a team of Quality Systems & Compliance managers/specialists and provide leadership to the team.
- Manage all Quality Systems & Compliance activities, supporting the development of the overall quality strategy for the site.
- Maintain and monitor processes for Document Management, Change Control, Deviation and CAPA Management, Inspections and Audits.
- Ensure regular assessments of compliance and effectiveness of Quality System requirements are performed and reported to the leadership team.
- Champion continuous improvements efforts to establish an effective and efficient Quality Management System in compliance with cGMP guidelines and corporate requirements.
- Coordinate and manage customer audits and health authority inspections (e.g. Swissmedic, FDA, etc.).
- Implement the Lonza culture via openness for innovations and change, cooperative teamwork, and continuous improvement.
**Requirements:**
- Bachelor or Master in Science or Engineering.
- Several years of experience in pharmaceutical manufacturing, preferably in a Quality & Compliance function.
- Strong background in cGMPs and Quality Management Systems.
- Very good communication skills and interaction with all kinds of interfaces within the organization and with regulatory agencies.
- Structured, focused, and well-organized working attitude, open-minded for new ideas and suggestions, agile, highly motivated, and dynamic drive.
- Sound experience in representing Quality and Compliance in large investment projects, from planning to successful health authority inspections.
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