- Location
- Cambridge, UK · 418 Cambridge Science Park Milton Road Cambridge Cambridgeshire CB4 0PZ
- Department
- Quality Assurance
- Education
- Bachelor
- Source
- Greenhouse
Description
OGT is a leading global provider of clinical and diagnostic genomic solutions. We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medicines.
An opportunity has arisen in our Operations team for a Head of Quality to lead our Quality function and ensure our Quality Management System remains effective, inspection-ready and aligned with regulatory requirements. This is a key leadership role, supporting product quality, operational excellence and continuous improvement across the organisation.
You’ll lead and develop the Quality Assurance and Quality Control teams, working closely with cross-functional stakeholders to embed a strong quality culture and ensure our products, processes and systems consistently meet the highest standards.
Your duties will include:
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.
Application is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.
Please note that we will need to establish your right to work during the recruitment process.
Skills
FDACompliance