Quality professionals with GxP-regulated experience and eQMS expertise will find this leadership role in a genomic solutions company in Cambridge, UK.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from OGT via Greenhouse
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.
Source: OGT careers (Greenhouse)