Head of Quality & QMS Excellence

OGT; Cambridge; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

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

Job summary

OGT is a global provider of clinical and diagnostic genomic solutions seeking a Head of Quality to lead the Quality function and align with regulatory standards. You will manage QA and QC teams, drive the QMS, and ensure inspection readiness across the organisation, supporting product quality and continuous improvement.

You will collaborate with cross-functional teams including Regulatory, Manufacturing, and IT to embed a strong quality culture and deliver compliant, high-quality products.

Qualifications

• 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.
• 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.

Responsibilities

• 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.

Skills

GxP-regulated experience

Quality management

eQMS

Good Documentation Practice

Cross-functional collaboration

Communication skills

People management

Education

Bachelor’s degree in a scientific or related discipline

Job description

OGT is a global provider of clinical and diagnostic genomic solutions seeking a Head of Quality to lead the Quality function and align with regulatory standards. You will manage QA and QC teams, drive the QMS, and ensure inspection readiness across the organisation, supporting product quality and continuous improvement.

You will collaborate with cross-functional teams including Regulatory, Manufacturing, and IT to embed a strong quality culture and deliver compliant, high-quality products.