QC Operations Manager

Overview

In this role, you lead QC laboratory operations in a highly regulated pharmaceutical environment to ensure testing meets specifications and timelines. You will drive quality, compliance, and continuous improvement while safeguarding patient safety. You collaborate with cross-functional teams and third parties to resolve issues and implement improvements. This is an impactful opportunity to shape QC practices in a GMP-focused setting.

Responsibilities

• Lead and oversee QC laboratory operations and testing activities
• Approve QC testing results for bulk, stability, and finished products
• Approve or reject incoming materials and packaging components per GMP
• Author, review, and approve SOPs, analytical methods, protocols, reports, and lab documents
• Ensure laboratory equipment is maintained, calibrated, and compliant
• Lead investigations for OOS and OOT results with effective CAPA implementation
• Coach and develop QC staff through performance management and training
• Coordinate analytical testing with third-party labs and contract partners
• Support change controls, method transfers, product quality reviews, audits, and regulatory inspections
• Drive continuous improvement initiatives across the lab
• Escalate and resolve quality issues appropriately

Key requirements

• Significant QC experience in a pharmaceutical manufacturing environment
• Strong GMP, Quality Assurance, Quality Systems, and Regulatory Compliance knowledge
• Proven leadership and people-management experience
• Experience managing lab investigations, deviations, CAPAs, and quality systems
• Strong technical and scientific judgement for complex data analysis
• Excellent communication, presentation, and stakeholder management skills
• Ability to build effective cross-functional relationships (Quality, Production, Regulatory, external partners)
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

• Leadership and team development
• Decision making and problem solving
• Influencing and motivating teams
• GMP and regulatory compliance knowledge
• Quality systems and QA processes
• CAPA management and deviation handling

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