Associate Director - Quality Assurance
Barden
- Limerick
- Permanent
- Full-time
- Be an active member of management team understanding the business and their role to ensure the business objectives are met.
- Supervision and coaching of their QA team members including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
- Manage training, qualification and performance of the team. Set job expectations and goals for individuals linked to team/site goals.
- Communicate appropriately with team members regarding site objectives and team business.
- Ensures that adequate resources are in place to support operations, new product introductions, batch disposition and quality system activities and productivity/continuous improvement initiatives in their area of responsibility.
- Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, procedures, annual product reviews and validation documentation.
- Responsible for the escalation of critical quality issues as appropriate to Quality Management consistent with site procedure on Notification to Management.
- Provides technical leadership and advice for key Quality issues.
- Identify, prioritise, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs.
- Maintain a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by regulatory agencies.
- Promote continued alignment in Quality assurance business processes.
- Specifically, during the startup phase (2023 to 2025) this role will be expected to be a collaborative, inclusive, energetic leader and support the broader team.
- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence.
- Develop and implement the systems and processed needed to run the site, leveraging existing knowledge and practices where necessary, but also incorporating external experiences and learning.
- Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
- Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.
- Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
- Preferred > 6 years GMP Manufacturing experience and at
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