Associate Director
3 weeks ago
Associate Director - Site Data Integrity Lead (Quality Systems) This leadership role is responsible for ensuring the quality, integrity, and regulatory compliance of GxP computerized systems across manufacturing, laboratory, and warehouse environments within a modern biopharmaceutical facility. The position will focus on data governance, computer system validation, and quality oversight of digital systems used in regulated operations. Responsibilities: Quality Systems & Data Integrity: Implement and maintain global quality and data integrity standards across all GxP systems Provide QA governance for IT, manufacturing, warehouse, and laboratory systems. Oversee policies and procedures related to CSV and data management. Perform risk assessments, inspections, and floor-based monitoring to ensure regulatory compliance (e.g., cGMP, 21 CFR Part 11, Annex 11). Ensure robust documentation and management of validation, change control, deviations, and CAPA processes. Lead data governance initiatives including mapping, lifecycle management, and KPI monitoring. Support digital systems including MES, DeltaV, DCS, LIMS, ELN, SAP, and other enterprise platforms. Computer System Validation (CSV): Ensure GxP systems meet CSV requirements and align with global regulatory expectations. Oversee the validation lifecycle including planning, testing (IQ/OQ/PQ), and periodic reviews. Review and approve validation documentation and risk-based approaches. Regulatory Compliance & Inspection Readiness: Act as Quality SME for data integrity and computerized systems during audits and inspections. Maintain inspection readiness across supported systems. Monitor evolving regulations and update site policies accordingly. Support audit preparation, execution, and follow-up activities. Continuous Improvement & Strategy: Identify and drive improvements in system integration, data flow, and validation practices. Support digital transformation initiatives focused on data visibility and compliance. Align local practices with broader organizational strategies and data governance frameworks. Training & Leadership: Deliver training on data integrity, CSV, and regulatory compliance. Mentor internal teams to build expertise in quality oversight of computerized systems. Promote a culture of compliance and continuous learning. Requirements: Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality, or related field. Advanced degrees (MSc, PhD) are advantageous. 10+ years in quality assurance, CSV, or data governance within a regulated life sciences environment. In-depth knowledge of global regulatory expectations (FDA, EMA, MHRA, etc.) Experience with GxP laboratory and manufacturing systems (e.g., LIMS, ELN, MES, DeltaV). Proficiency in GAMP 5, QRM, and digital system compliance. Strong leadership, communication, and cross-functional collaboration skills. Skills: CSV LIMS QMS Quality Management Systems
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Associate Director QCR
2 weeks ago
Limerick, Ireland CAI Full timeJoin to apply for the Associate Director QCR role at CAI 4 days ago Be among the first 25 applicants Join to apply for the Associate Director QCR role at CAI Get AI-powered advice on this job and more exclusive features. The Position is Hybrid, not 100% remote (many projects will require on-site presence) Position Description: As the Associate...
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Associate Director
3 weeks ago
Limerick, Ireland Eli Lilly And Company Full timeOverviewBe among the first 25 applicants.At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back...
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Associate Director Site Data Integrity Lead
2 weeks ago
Limerick, Ireland Scientificjobs Full timeAssociate Director Site Data Integrity LeadOur client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director Site Data Integrity Lead to join their team on a permanent basis.Responsibilities: Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)Lead implementation...
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Associate Director, Planning Manager
4 weeks ago
Limerick, Limerick, Ireland WiiGroup Full timeOur MissionAt WiiGroup, our mission is to revolutionise the AEC industry through innovative solutions, cutting-edge technology, and a relentless focus on client satisfaction. We strive to exceed expectations, leverage digitalisation, and shape the future of construction globally. Through innovative solutions and cutting-edge technologies. With a passionate...
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Associate Director – Corporate Audit – Limerick
3 weeks ago
Limerick, Ireland Grant Thornton Ireland Full timeAssociate Director – Corporate Audit – Limerick page is loaded## Associate Director – Corporate Audit – Limericklocations: Limerick: Corktime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR7926**Associate Director – Corporate Audit – Limerick**Grant Thornton (GT) has nearly 3,000 people across 9 offices in Ireland, the Isle of...
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Associate Director
19 hours ago
Limerick, Ireland Eli Lilly And Company Full timeOverviewLilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Associate Director
2 days ago
Limerick, Ireland Scientificjobs Full timeAssociate Director – Manufacturing & Quality Technical Learning & DevelopmentOur client, a global pharma company, are currently recruiting for an Associate Director– Manufacturing & Quality Technical Learning & Development to join their team on a permanent basis. AsAssociate Director for Technical Learning & Development, you will lead site-level learning...
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Associate Director
2 weeks ago
Limerick, Ireland Eli Lilly And Company Full timeOverviewLilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Limerick, Ireland Eli Lilly and Company Full timeOverview Be among the first 25 applicants. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give...
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Associate Director – Corporate Audit – Limerick
3 weeks ago
Limerick, Ireland Grant Thornton Ireland Full timeAssociate Director – Corporate Audit – Limerick page is loaded## Associate Director – Corporate Audit – Limericklocations: Limerick: Corktime type: Full timeposted on: Posted 2 Days Agojob requisition id: JR7926**Associate Director – Corporate Audit – Limerick**Grant Thornton (GT) has nearly 3,000 people across 9 offices in Ireland, the...
