Our client, a leading pharmaceutical company are seeking a Quality Compliance Manager who will be responsible for compliance with the Quality and Regulatory requirements for combining medicinal and device products assembled and packed in Dublin.
This role is also responsible for overseeing the compiling of technical and quality documents in support of submissions to the relevant authorities, for obtaining and maintaining the required medicinal product manufacturing authorisations. Reports directly to the Snr. Quality Manager.
Essential Duties and Responsibilities:
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 to client 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 feed-back to relevant stakeholders.
Liaise with Customers and regulatory agencies on behalf of client.
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.
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 process with respect to compliance / value add.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
Minimum requirement is a degree programme in either pharmacy, chemistry, biology, microbiology or equivalent
At least 5 years in a Medical Device / Pharmaceutical environment, including practical experience of working within a highly regulated quality management system (QMS).
Preferred Knowledge, Skills and Abilities:
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
Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
Must have excellent written and verbal communication skills.
Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Great remuneration package and benefits come with this role.
For more information, please apply through the link provided for the attention of Stefan Ion or email your CV to [email protected] Please submit your updated CV in Word Format.
If you are living in Ireland and hold a valid work permit we would love to hear from you, if however you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search
Osborne are proud to be an Equal Opportunity Employer.