The Ideal Candidate:
- Strategic
- Collaborative
- Proactive
- Adaptable
What You'll Do:
- 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.
What You'll Need:
- 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
Skills Required
- 8 years of experience in cGMP secondary packaging and labeling operations within pharmaceutical or clinical supply chain
- Experience supporting clinical trial materials (preferred)
- Strong working knowledge of cGMP requirements and global regulatory standards for packaging and labeling
- Demonstrated expertise in label design, artwork development and proofing, MBR management, and packaging documentation with rigorous version control
- Hands-on experience using ERP systems for production scheduling and BOM management
- Proven ability to collaborate with Project Management, Regulatory, Quality, Procurement, and external suppliers
- Strong vendor and stakeholder management capabilities focused on compliance and on-time delivery
- Experience supporting and coordinating client and regulatory audits related to packaging and labeling
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.

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