Site Quality Director
The Quality Leadership Position has become available in a leading global Pharmaceutical company that delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and a range of services. This organisation sells into over 100 countries with over 10,000 employees, making it one of the largest healthcare organisations in its sector.
This business is expanding heavily in Ireland, having invested significantly in its flagship manufacturing operation in the Leinster region. To head up all Quality activities at the site, they are seeking a skilled Site Quality Director.
* Assess product introductions and major capital projects for Quality and validation considerations.
* Collaborate with site and global functions to ensure compliant, on-time recommissioning and commercial supply of product to the network.
* Establish and maintain an effective Quality organisation managing Quality Systems, Method Validation, Analytical Testing, Registration, and Batch Release.
* Lead the development of compliant, robust, and lean Quality Management Systems.
* Recruit, train, and appraise Quality management staff, ensuring ongoing development and succession planning is in place and active.
* Implement governance systems to monitor process performance and product quality, assuring continued capability and suitability.
* Lead continuous improvement initiatives to enhance compliance, quality systems, and product lifecycle performance.
* Monitor and communicate new GMP compliance standards to the site.
* Act as the lead representative for the site during external GMP audits and regulatory inspections.
* Partner with site leadership to integrate Quality with other operational areas effectively.
* Ensure all production complies with cGMP and applicable quality regulations.
* Make final decisions on non-routine batch dispositions.
* Liaise with Quality, supply organisations, and customers on significant product supply issues.
* Develop and manage the annual Quality department operating plan and budget.
* Represent the site in corporate and industry Quality forums.
* Lead Safety Compliance within Quality and Laboratory functions, ensuring risk assessments, training, and safety measures are in place and effective.
* Investigate incidents and implement preventative actions as required.
Requirements:
* Training & Experience in Change Execution Methodology.
* 10 years+ experience in a pharmaceutical manufacturing environment, including significant management roles.
* Comprehensive knowledge of worldwide GMP regulations and expectations governing facilities, equipment, and procedures for the manufacture and control of pharmaceutical product as per ICHQ7.
* Demonstrated experience of leading and driving results in continuous improvement projects (e.g. Right First Time (RFT), Operational Excellence/Lean Projects).
* Success in developing, implementing, and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.
What We Offer:
* A challenging opportunity to lead a Quality team and drive quality and compliance improvements in a global Pharmaceutical company.
* Opportunities for career development and progression within the company.
* A competitive salary and benefits package.
How to Apply:
Apply online or contact us for a confidential discussion.