QA Regulatory Compliance Lead - Clinical Supply Chain

PCI Pharma Services; Dundalk (MD); On-site; USD 72,000 - 99,000; Full time

Job summary

PCI Pharma Services is seeking a QA Regulatory Compliance Specialist to establish and manage third-party and clinical supply chains within PCI's regulatory compliance function. You will support right-first-time QP release and partner with clients and internal stakeholders to oversee regulatory changes across multi-site supply chains.

The role ensures GMP-compliant product lifecycle management and requires collaboration across quality systems, supplier qualifications and deviations handling.

Qualifications

• Bachelor's degree in a scientific, technical or engineering discipline (or associate degree / diploma / certificate)
• Minimum 5 years' experience within the pharmaceutical/biological industry including at least 2 years in regulatory/compliance
• Strong working knowledge of EU regulatory requirements for pharmaceuticals and GMP

Responsibilities

• Create and maintain Product Specification Files for clinical supply chains
• Develop and manage Quality Systems and Compliance frameworks
• Maintain the Approved CMO list for clinical supply chains
• Manage Supplier Management Programme including supplier audits and QTA/qualification
• Prepare QP declarations and Product Quality Reviews for third-party releases
• Review third-party changes for regulatory impact
• Generate SOPs, forms, job aids and work instructions in MasterControl

Job description

PCI Pharma Services is seeking a QA Regulatory Compliance Specialist to establish and manage third-party and clinical supply chains within PCI's regulatory compliance function. You will support right-first-time QP release and partner with clients and internal stakeholders to oversee regulatory changes across multi-site supply chains.

The role ensures GMP-compliant product lifecycle management and requires collaboration across quality systems, supplier qualifications and deviations handling.