Our client requires an experienced Quality Manager to undertake a project in Germany. This role will involve setting up, maintaining and developing an effective quality system between two sites of the company.
The Quality Systems Manager, provides strategic and tactical leadership for all aspects of the Quality Systems department responsible for the QS applications and GxP processes. The successful candidate will be responsible to oversee compliance planning, verification and validation activities during the entire life cycle of the computer systems.
- Plan, lead and conduct verification and validation activities.
- Secures appropriate resources to execute the program compliantly, effectively and efficiently. Identifies opportunities to continuously improve quality systems consistent with business objectives.
- Set strategic direction for the Quality Systems policies and activities for QS tools and GxP applications.
- Liaises with IT, Quality, Operations and business owners to provide strategic input and direction for Quality System and GxP landscape.
- Quality System and GxP compliance program owner.
- Maintain and provide IT risk assurance the requirements for Quality related process validation and verification.
- Direct operations of Quality Systems department to assure optimum performance and compliance.
- Provide leadership to support business changes and process improvements.
- Ensure adequate resources are available for project support.
- Provide strategic quality and compliance input and direction for computer system applications. Reviews and approves compliance plans, compliance analysis and protocols.
- Ensures company policies and procedures are in place to deliver to Quality System and GxP compliance goals and objective.
- SME expert for and provides support for external audits.
- Liaison with Quality leadership team in compliance data analysis to identify areas for improvement.
Experience, Education and Skills:
- Minimum 8-10 years of experience working with Quality Systems IT and/ or GxP applications in Medical devices diagnostics, pharmaceutical or other highly regulated industry required.
- Experienced in specification development, and verification validation protocol writing. General familiarity with IT system architecture and hardware required.
- Proven track record in participating in leading teams.
- Interacts with global regulatory bodies as needed to support audits.
- Strong communication skills required.
For further information on this Quality Manager role in Germany please contact Cliona O?Malley on 091730022 / email@example.com
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