Head of Quality

Quality Team Management & Quality Management System

• Lead and develop the Quality Assurance and Quality Control teams, building a high-performing and engaged department with clear goals, objectives, and accountabilities
• Ensure the Quality Plan is delivered on time and to the required standards
• Provide Quality Operations oversight across the organisation
• Act as a core team member for applicable projects, providing Quality input and decision-making support
• Promote a culture of continuous improvement within the Quality organisation by identifying improvement opportunities and championing effective initiatives
• Ensure the Quality Management System, including the eQMS, is established, implemented, maintained, and continually improved in line with applicable regulatory standards
• Manage and mentor the Quality Team members so they provide consistent specialist guidance on quality requirements and compliance expectations
• Maintain accurate QMS process documentation and ensure it supports compliance, operational effectiveness, and continuous improvement
• Oversee day-to-day execution of the QMS to support effective compliance and operational control
• Maintain and promote awareness of applicable regulatory and QMS requirements throughout the organisation
• Report on QMS performance, including Quality Objective KPIs, audit outcomes, compliance with legal and other requirements, and regular monitoring of process performance
• Consider interdependencies between Quality Assurance, IT, Regulatory, Clinical, Manufacturing, Supply Chain, and other relevant functions when developing or improving quality system processes.

Product, Production Process & Equipment/Facilities

• Ensure released product meets release criteria and act promptly to isolate, correct and implement corrective actions where product/process nonconformance is detected
• Ensure documentation and processes follow ALCOA principles and Good Manufacturing Practice expectations
• Ensure equipment, software, environment, people, products, and processes remain compliant with the QMS, with timely corrective action where required
• Authorise release only for product that meets specified quality criteria for sale or evaluation
• Support regulatory inspections and external audits by providing expert input, presenting QMS information clearly, coordinating responses, and supporting timely resolution of requests
• Provide expert quality systems input into product/process nonconformance, Deviations, CAPA, Change Control, audit findings, and other quality records, applying sound judgement to support root cause evaluation, risk assessment, corrective action planning, and effectiveness monitoring
• Influence stakeholders across disciplines to adopt compliant, effective, and sustainable quality system practices.

What we’re looking for in you:

Essential

• Bachelor's degree in a scientific, quality, regulatory, technical, or related discipline with >5 years relevant experience in the pharmaceutical, biotechnology, clinical research, or similarly regulated industry; or equivalent combination of education and experience
• Significant experience working in a GxP-regulated environment, with demonstrated knowledge of quality management systems, electronic systems, regulatory expectations, and inspection/audit readiness
• Experience in a management role, preferably in a regulated quality context
• Demonstrated experience applying quality metrics, KPIs, trend analysis, and risk-based approaches to assess QMS performance and drive continuous improvement
• Experience with at least one eQMS
• Working knowledge of Good Documentation Practice
• Demonstrated ability to collaborate with cross-functional teams, foster support, and influence stakeholders across the company
• Excellent proven written and oral communication skills.

Desirable

• Qualification in 6-sigma
• Knowledge of process and equipment validation in the Medical Device industry
• Knowledge of computer systems validation (CSV) in the Medical Device industry
• Knowledge of IVDR requirements and commercialisation
• Technical and/or scientific knowledge related to IVD manufacture and distribution
• Technical and/or scientific knowledge related to CDX manufacture and distribution
• Previous experience with manufacturing medical devices to FDA 21CFR requirements.

In return you’ll receive

• Competitive salary
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• Private Dental Insurance
• Group Income Protection
• Group Life Assurance
• 25 days holiday plus UK bank holidays
• High Street Discount Scheme.