QA Manager - Clinical Trials (Ennis, Co Clare or Limerick City Based)

Why Choose Vitalograph? At Vitalograph, we're committed to providing a workplace that values professional growth and offers opportunities to lead within a global, innovation-driven environment. As an established leader in medical respiratory diagnostics, you'll engage in meaningful work with cutting-edge technology that impacts patient lives worldwide. Here's what we provide to support your success:

1. Comprehensive Pension Contribution - Supporting your financial security and future.
2. Private Health Insurance - Prioritising your health and peace of mind.
3. Educational Assistance Program - Encouraging ongoing professional development.
4. Clear Career Progression Path - Offering ample opportunities for career growth and impact.

About Us With over six decades of expertise, Vitalograph has redefined respiratory diagnostics through our innovative devices, software, and solutions. Trusted by healthcare providers in more than 100 countries, our advanced technology aids in the diagnosis of respiratory conditions. Headquartered in the UK with global operations across Ireland, Germany, and the USA, we are continuously growing and evolving. Your role as a QA Manager: You will ensure best practice, identify risks and mitigation strategies, enhance local Standard Operating Procedures, interpret regulatory and audit requirements and provide guidance, training and support for QA teams. Responsibilities:

1. Management and ultimate ownership of all QA processes within the Cough Analysis QA Team.
2. Training & Monitoring.
3. Weekly & Project QA.
4. Algorithm Validation.
5. Provide line management, guidance, training and mentoring to QA Functional Managers.
6. Perform required managerial tasks for staff such as performance review and setting clear goals and objectives.
7. Co-ordinate with internal and offshore disciplines to resolve irregularities that may arise.
8. Provide expertise and leadership in Quality Compliance to the wider organization and ensure that all personnel are aware of Vitalograph's requirements for quality.
9. Keep the direct line manager informed of any quality issues within the department/office which require attention.
10. Create an environment that motivates people, acting as a mentor and sharing expertise.
11. Monitor metrics and QA reports and address performance issues and trends accordingly.
12. Effectively implement and maintain Clinical Quality Assurance procedures and processes in adherence with SOPs, ICH GCP and appropriate regulations.
13. Deliver continuous improvement initiatives regarding quality and processes.
14. Monthly reporting on metrics and all team activities.
15. Manage the allocation of workload and supervision of QA teams in relevant office(s).
16. Management of TAT to ensure all project deadlines are met.
17. Liaise with project co-ordinators and team management to ensure all projects are adequately QA resourced for both current and future projects.
18. Ensure that all work and tasks carried out within the QA team are consistent and compliant with Vitalograph's QA systems.

To Succeed You Will Need:

1. Bachelor's Degree or local equivalent in science or equivalent degree/experience.
2. Minimum of 3 years' active experience in a quality/regulatory compliance position, with a proven track record of success in managing quality projects and teams with broad quality assurance experience.
3. Minimum of 3 years directly managing a team.
4. In-depth knowledge and understanding of clinical trial process.
5. Thorough knowledge of current regulatory and ICH GCP requirements and experience with global regulations and guidelines.
6. Highly developed problem-solving skills and the ability to resolve difficult conflicts.
7. Strong people management and communication skills with the ability to influence others and gain commitment; Demonstrated training skills, including the ability to give constructive feedback.
8. Ability to multitask and to work efficiently and independently.

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