Exciting Opportunity to join Sanofi!
Great salary and benefits!
To ensure the quality and compliance systems at Sanofi Waterford are effectively implemented, maintained and enhanced.
Must have a strong Quality Systems background within Pharmaceuticals or Medical Devices.
We have an exciting opportunity to join our team in Waterford!
The successful candidates role will be to ensure the quality and compliance systems at Sanofi Waterford are effectively implemented, maintained and enhanced.
- Oversees the day to day management of Quality Systems and Compliance, directing the workload of the QS & Compliance team
- Leads the continuous improvement of the quality systems and the implementation of corporate standards
- Ensures the team is being led and organised in an effective manner and is active in identifying and implementing areas for improvement
- Ensures that the performance of designated quality systems i
- are routinely evaluated and systematically monitored for compliance to regulatory requirements
- Manages quality management review processes at site
- Manages preparations for external agency/corporate/supplier inspections
- Manage team development
- Manages introduction of Sanofi Quality IT solutions to site
- Comply with all relevant safety requirements
- Third level qualification (Degree in Science, Engineering or Business preferred).
- Formal auditing qualification is desirable
- Lean sigma tools and techniques qualification.
- At least 10 years in the Healthcare sector with 4-5 years’ experience in a similar or equivalent role, working across site and corporate structures
- Experience of manufacturing operations and dealing with regulatory authorities is highly desirable.
Skills & Knowledge
- Extensive knowledge of cGXP in a regulated environment and understanding of how they impact on site
- Strong interpersonal skills to ensure appropriate action is obtained on quality and compliance related issues at the site and at corporate level where necessary
- Demonstrates ability to work effectively, both independently and in a team environment, in an atmosphere of multiple projects, shifting priorities and deadline pressures
- Effective personnel and project management skills
- Lean sigma tools and techniques