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As a vital member of the Senior Leadership Team, the Head of Quality & PRRC (Person Responsible for Regulatory Compliance) is responsible and oversees the strategic direction and execution of Quality Control and Quality Assurance systems across multiple sites. This role ensures regulatory compliance, oversees Quality functions, drives a culture of proactive quality, and leads teams to embed quality across operations. As a member of the Senior Leadership Team, the Head of Quality & PRRC contributes to, and executes, priorities and strategic initiatives for Cork Operations.

Key responsibilities:

• Acts as the Management Representative with the authority and responsibility to ensure that the Quality System is implemented and maintained to applicable quality and regulatory requirements.
• Acts as the PRRC, as per relevant regulatory and procedural requirements, to ensure compliance to Article 15 of the EU MDR 2017/745 and Article 15 of the EU IVDR 2017/746
• Ensuring the operation of an effective internal audit program
• Chair the Management Review process ensuring that all issues relevant to maintaining the continuing suitability and effectiveness of the Quality System are reviewed at least annually.
• Defines and oversees the execution of the Quality strategy aligned with organizational goals.
• Communicates quality objectives and performance effectively to all stakeholders, including senior leadership and regulatory bodies.
• Ensures adherence to safety and quality regulations, specifications, and policies to enable a safe working environment and strong delivery to the customer.
• Promotes awareness of regulatory and customer requirements and expectations throughout the organisation.
• Ensures that manufacturing operations conform to quality standards, applicable Quality, Customer and Regulatory specifications.
• Ensures product, process and raw material specifications remain current, and that product released into inventory is in compliance with defined specifications.
• Liaises with government Regulatory departments & Notified Bodies to ensure compliance with standards.
• Fosters a collaborative, proactive quality culture to motivate teams to actively engage in identifying opportunities for improvement of quality processes.
• Develops and oversees risk management frameworks for risk reduction.
• Provides oversight and coordination of all quality activities across Cork Operations.
• Champions initiatives for continuous improvement in quality processes and systems.
• Role models coaching and mentoring across functions to develop team and individual performance.
• Ensures compliance with all applicable Environmental, Health and Safety legislation & adherence to procedures for areas of responsibility.