Our client is a very ambitious fast growing multinational pharmaceutical company setting up its global compliance function in Dublin. Ambitious future plans for growth have led to the need for newly created role Quality Systems Manager (QP) who will report directly to Global External Manufacturing Quality Systems and Quality Assurance Director (Quality Director).
The Quality Systems Manager (QP) will have responsibility for the development, implementation and performance of Quality Assurance systems for the company’s Ireland operation and Global External Manufacturing QA. They will create and maintain QA systems in support of the Manufacturing Importation Authorisation (MIA), Wholesale Distribution licence (WDA) and Active Substance Registration (ASR). The Quality Systems Manager (QP) will also work on key activities for Global External Manufacturing QA.
The key responsibilities assigned to the Quality Systems Manager (QP) are related to Quality Assurance Systems at the company’s Ireland Limited and Global External Manufacturing QA. These responsibilities include:
- Provide Quality Systems expertise in support of GxP authorisations and the role of Marketing Authorisation Holder (MAH).
- Provide quality and compliance support for Quality Systems.
- Develop and enhance the Quality Management Systems.
- Batch release for Externally Manufactured product (EU Qualified Person or QP eligible).
- Ensure operations are in compliance with cGMP and cGDP.
- Collaborating effectively with a Global network of colleagues to promote and enhance Quality processes.
- Perform audits as necessary.
- Support Global External Manufacturing QA.
- Manage and Deliver projects.
- Identify opportunities for Continuous Improvement.
- Coach and mentor quality colleagues.
- Travel as required.
- Bachelor's degree in a related scientific discipline with relevant experience.
- Eligible to act as a European Qualified Person, certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.
- Extensive knowledge of QA systems in GMP & GDP environments.
- Extensive experience working within licensed GMP facilities, preferably in QA, line management and production of Medicinal Products or Medical Devices.
- Experience in managing BOH inspection and quality management systems within the EU.
- Ideally over 7 years’ experience working in the pharmaceutical industry.
- Ideally over 4 years’ experience in management of QA.
- Ideally Lean Six Sigma trained and experience delivering Lean projects.
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