Quality Compliance Manager- Dublin.
Ref No: SF17264
Co. Dublin, Ireland
Quality Compliance Manager- Dublin.
This role is being offered on a 1 year fixed-term contract basis.
In this role you will have responsibility for compliance with the quality and regulatory requirements. This role is also responsible for overseeing the compiling of technical and quality documents in support of submissions to the relevant authorities, and for obtaining and maintaining the required medicinal product manufacturing authorisations.
- This role will be responsible for the upgrading and maintaining 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 of quality systems, procedures and policies.
- Manage the Quality Compliance team, 1:1 meetings and Training & Development Plan for Reports
- Provide regulatory guidance to the business including regulatory training, keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact, and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feedback to relevant stakeholders
- Liaise with customers and regulatory agencies.
- Supply Chain QA, responsible for the review and approval of all suppliers on the AVL and their ongoing control through Supplier
- Corrective Action Report management, vendor rating and audit management.
- Develop, lead and maintain a comprehensive audit readiness program to ensure internal and external compliance
- Drive standardisation of QMS in line with parent company
- 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.
- Conduct various trend analyses to identify short and long-range patterns so that recommendations can be made in order to effect continuous improvement necessary to satisfy customer requirements and drive improvements
- Work closely with the NPI and Operations Department to ensure that programs are introduced in a manner that complies with the appropriate regulatory requirements, customer specification and consistent with Quality Management Systems (QMS)
- Lead continuous improvement initiatives to challenge the quality systems processes with respect to compliance / value add.
Qualifications & Experience:
- Minimum requirement is a degree in pharmacy, chemistry, biology, microbiology, engineering, or equivalent with at least 5 years' experience in a Medical Device / Pharmaceutical environment, including practical experience of working with 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 European or US authorities.
- Accredited lead auditor against recognised quality standards in support of internal and supplier audits
- Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
- Must have excellent written and verbal communication skills.
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