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A leading global Pharmaceutical company dedicated to supporting customers and their businesses in ever better ways.
This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services.
Selling into over 100+ countries with with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector.
Expanding heavily here in Ireland with the acquisition of a number of maufacturing sites, this business has invested heavily in its flagship manufacturing operation in the Leinster region and currently require a Site Quality Director to head up all Quality activities at the site.
The Position: Assess product introductions and major capital projects for Quality and validation considerations.
Collaborate with site and global functions to ensure compliant, on-time recommissioning (where applicable) and commercial supply of product to the network.
Establish and maintain an effective Quality organization 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 is 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 organizations, 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.
Developing and managing the annual Operating Plan for department and Site Quality Annual Plan.
Overseeing Site capital investment to drive quality and compliance.
Developing QA/QC budget and resources planning for the Site.
Lead Site Quality Management Review, Site Quality Council and Recall Committees.
The Person: Training & Experience at application of Change Execution Methodology.
10 years+ experience, including significant management roles, in a pharmaceutical manufacturing environment.
Comprehensive knowledge of world-wide 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.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.
Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Manufacturing, Quality Assurance, and Science Industries Chemical Manufacturing, Chemical Raw Materials Manufacturing, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at HRM - Delivering Leadership Talent by 2x
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