QC Operations Manager

Hertfordshire Source: WhatJobs

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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)