Quality Compliance Manager – Fixed Term Contract
Our client, based in Dublin is looking for a Quality Compliance Manager, this is a maternity contract.
Essential Duties and Responsibilities:
- Reporting to the Quality Manager, this role will be responsible for the upgrading and maintaining of the quality systems to meet the requirements of the European and US Medicinal Product and medical device requirement, this includes the establishment, maintenance and continuous improvement quality systems, procedures and policies.
- Manage the Quality Compliance team, 1:1 meetings and Training & Development Plan for Reports
- Liaise with Customers and regulatory agencies.
- Supply Chain QA responsible for the review and approval of all Suppliers
- Drive standardization of QMS
- Develop reports / presentations on the status of the compliance program for senior management team
- Embed QMS management principles in the organisation & drive continuous improvement
- Liaise with the QP on performance of the QMS and emerging quality trends and risks.
- Lead continuous improvement initiatives to ‘challenge’ the quality systems processes with respect to compliance / value add.
- Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent with at least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
- Knowledge of and experience in setting up and maintaining a QMS which meets the legislative requirement of human medicines and medical devices in the EU and USA and the ISO13485 standard.
- Have experience in the facilitation of quality risk management coupled with a good working knowledge of ISO14971
- Experience of hosting regulatory audits from either the European or US authorities.
- Accredited lead auditor against recognised quality standards in support of internal and supplier audits