Quality Operations Manager

We are looking for an experienced and driven Quality Operations Manager to join our Quality Operations team. In this highly visible role, you will be responsible for leading Quality Assurance and Quality Operations activities, ensuring compliance across the manufacture, packaging, testing, storage, and distribution of marketed pharmaceutical products.

Working closely with internal teams, affiliates, and third-party manufacturing partners, you will play a key role in maintaining and enhancing our Quality Management System (QMS), supporting batch release activities, driving continuous improvement initiatives, and ensuring ongoing compliance with global GMP and GDP requirements.

This is an excellent opportunity for a quality professional who is passionate about compliance, operational excellence, and making a meaningful impact within the pharmaceutical industry.

As Quality Operations Manager, you will:

• Champion a culture of quality, compliance, and continuous improvement across the site.
• Ensure adherence to Eisai Quality Systems, GMP, GDP, and applicable regulatory requirements.
• Support batch review, release, and distribution activities to ensure timely supply of products.
• Lead and support Quality Assurance activities across manufacturing, packaging, testing, storage, and distribution operations.
• Maintain and optimise the TrackWise Quality Management System and associated quality processes.
• Represent Quality Operations during regulatory inspections, customer audits, and third-party audits.
• Lead the Product Quality Review (PQR) programme, including trend analysis and reporting.
• Review and approve deviations, investigations, CAPAs, change controls, complaints, validation documents, and other quality records.
• Author, review, and approve SOPs and quality documentation.
• Monitor key quality metrics and contribute to Quality Management Review activities.
• Deliver GMP and quality systems training, coaching, and mentoring.
• Provide quality leadership on cross-functional projects and continuous improvement initiatives.
• Support implementation of new GMP requirements and site inspection readiness programmes.
• Act as a technical quality expert and provide support to the wider Quality Operations leadership team as required.

Essential Experience & Qualifications

• Highly experienced in a Quality Management or Quality Assurance leadership role within the pharmaceutical industry.
• Extensive knowledge of:
  • Quality Assurance and Quality Systems
  • GMP and GDP requirements
  • Pharmaceutical manufacturing and packaging operations
• Strong understanding of global GMP regulations and industry guidance, with the ability to interpret and implement compliance requirements.
• Experience managing quality systems and supporting regulatory inspections and audits.
• Demonstrated ability to analyse complex quality data and translate findings into actionable improvements.
• Strong Microsoft Office skills, including Excel, Word, and PowerPoint.