cGMP Production Manager
On-siteDublin, Leinster, Ireland
Job Summary
Execute and oversee GMP production activities, including room setup, batch execution, in-process checks, reconciliation, line clearance, and clean-down. Maintain production suites in a continuous audit-ready state, ensuring compliance with GMP, GDP, SOPs, and quality standards. Serve as a global production SME, providing real-time troubleshooting, escalation support, and technical guidance during operations. Verify readiness and compliance of materials, labels, packaging components, equipment, and documentation prior to batch execution. Create, review, and maintain MBRs and EBRs, ensuring accurate, timely, and compliant batch documentation. Develop, proof, issue, control, and reconcile label templates, artwork, and packaging layouts to meet regulatory, client, and protocol requirements. Partner with Project Management, Regulatory, and Quality to finalize packaging and labelling designs, layout drawings, samples, and client approvals. Maintain BOMs and related master data in ERP systems, ensuring accurate configuration, versioning, and updates. Support vendor coordination, sourcing decisions, and supplier qualification for packaging components, tooling, consumables, and equipment. Drive process optimization, change controls, system enhancements, and global standardization initiatives across Production and Global Supply Chain Operations.
Required Qualifications
- 8 years of experience in cGMP secondary packaging and labeling operations within the pharmaceutical or clinical supply chain environment, preferably supporting clinical trial materials
- Strong working knowledge of cGMP requirements and global regulatory standards governing pharmaceutical packaging and labeling
- Demonstrated expertise in label design, artwork development and proofing, MBR management, and packaging documentation, with rigorous version control and attention to detail
- Hands-on experience using ERP systems to support production scheduling, Bill of Materials (BOM) management, and operational workflow optimization
- Proven ability to think strategically, solve complex operational challenges, and collaborate effectively with cross-functional partners including Project Management, Regulatory Affairs, Quality Assurance, Procurement, and external suppliers
- Strong vendor and stakeholder management capabilities, with a consistent focus on compliance, accuracy, and on-time delivery
- Experience supporting and coordinating client and regulatory audits related to packaging and labeling activities
- Resume in English
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