About Us
We are part of a leading international group of fertility specialists, including CREATE Fertility and IVI London, providing world-class reproductive healthcare across the UK.
Our clinics are at the forefront of innovation, offering Natural and Mild IVF meaning,
gentler, safer approaches that use little to no fertility medication alongside a full range of advanced treatments, including IVF, IUI, ICSI and fertility preservation.
Together, we are committed to evidence-based treatments, cutting-edge technology and personalised, patient-focused care helping to give every patient the best possible chance of success.
Please note this can be based from any of our clinics around the country
The Role
The Quality Director is responsible for managing the company's quality program in line with Create/IVIRMA standards, the HFEA Act, the EU Tissue Directive and relevant professional codes of conduct.
The role includes analysing data, conducting audits and ensuring services meet the highest standards for patient care.
The Quality Director is expected to manage their workload effectively while working closely with the wider team. Additional duties may be assigned as required.
Duties and Objectives
* Develop and implement quality management system
* Develop and maintain systems to establish high standards relating to activities and products
* Develop and maintain systems to measure performance against established standards
* Monitor performance (in relevant areas) according to agreed standards and take necessary action to communicate/advise/assist according to performance levels
* Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal Create/IVIRMA quality management systems
* Establish and implement necessary communication strategy for the improvement and awareness of quality issues across all departments
* Report as necessary on changes in standards (internally and externally initiated) and on performance against standards
* Liaise with customers and suppliers where necessary (where impacting/affected by quality issues)
* Collaborate in defining Create/IVIRMA's Quality Policy and ensure its compliance across all clinics and departments.
* Oversee the establishment, maintenance, and improvement of the QMS manual for both IVI London and global clinics.
* Ensure patient confidentiality is maintained at all times in line with company policy, HFEA Code of Practice, and other relevant regulations.
* Support the Medical Director, Lab Director, Person Responsible (PR), Nursing Manager, and Lab Manager(s) in administering statutory, regulatory, and compliance requirements.
* Manage document control systems, ensuring that all documentation is up-to-date, version-controlled, and in compliance with HFEA regulations and other international standards.
* Keep abreast of the latest developments in HFEA, MHRA, GDPR/ICO, Home Office regulations, and other relevant regulators, ensuring that the team is informed of changes.
Core Knowledge and Understanding
* A deep understanding of all prevailing legislation, including the HF&E Act (and subsequent revisions), and the EU Tissue Directive
* a detailed knowledge of, and ability to apply, quality assurance and monitoring of quality control processes as per the Quality Manual;
Compliance and Regulation:
* Ensure that clinic operations comply with HFEA regulations and other relevant international standards where applicable, including ISO 9000, UNE179007, UNE179003, EFQM, and QH.
* Prepare for and oversee HFEA inspections, audits, and licensing activities, coordinating these efforts across multiple locations.
* Maintain up-to-date knowledge of regulations affecting clinic operations and ensure compliance through regular audits and inspections.
Risk Management:
* Identify potential risks to patient safety and clinic operations, developing strategies to mitigate these risks.
* Maintain and update the clinic's risk management plan, fostering a culture of safety and enhancing staff knowledge of patient safety and risk management.
* Develop and execute actions indicated by Medical Affairs to address patient risks and coordinate improvement activities across the organisation.
Training and Development:
* Develop and deliver training programs to ensure staff understanding and adherence to quality standards and regulatory requirements.
* Foster a culture of continuous improvement and quality awareness among clinic staff, ensuring completion of mandatory training.
Data Management and Reporting:
* Oversee the collection, analysis and reporting of quality metrics and patient outcomes.
* Prepare regular quality reports for senior management and relevant regulatory bodies, including the HFEA.
* Monitor quality indicators necessary for the correct control and evaluation of processes, ensuring continuous improvement.
* Ensure the KPI's of relevant clinics are submitted to the management team in the correct timeframe.
* Ensure the data is submitted to the HFEA in the correct timeframe and is accurate.
* Maintain KPI's of relevant centres and assist labs/individuals in the improvement and maintenance of performance.
* Use a database (such as Q Pulse) to report incidents, audits, quality improvements and track personnel and suppliers with respect to compliance.
Incident Management:
* Manage the reporting and investigation of incidents, non-conformances, and adverse events, implementing corrective and preventive actions to address identified issues.
* Coordinate the circuits of incidents and complaints, collaborating in their resolution and reporting to superiors any incidents that occur.
Patient Experience:
* Monitor and improve patient satisfaction through regular feedback, quality initiatives, and data analysis on patient perceptions and satisfaction with services.
* Address and resolve patient complaints in a timely and effective manner.
Continuous Improvement:
* Lead quality improvement projects aimed at enhancing patient care and clinic efficiency, standardizing procedures across global clinics.
* Collaborate in the design, execution, and improvement of healthcare and non-healthcare processes to reduce events that may lead to risks to patient safety.
* Coordinate activities aimed at improving processes in different areas of the organization, ensuring alignment with global quality objectives.
Personal Specification
* Highly professional attitude, diplomatic, flexible, and adaptable
* Innovative, self-motivated, reliable, and committed to professional development
* Detail-oriented with a commitment to accuracy and thoroughness
* Ability to work independently and as part of a team
* Proactive and forward-thinking approach to quality and compliance
* Must be able to visit all clinics within the Create/IVIRMA UK group as required
Qualifications
* Bachelor's degree in a relevant field (e.g., healthcare management, life sciences, quality management, engineering, chemical sciences, physics, pharmacy, or biology)
* Specific training in Management Systems and Quality Management Systems Auditing is an asset
Experience
* Minimum of 5 years of experience in a quality management role, preferably within a healthcare or fertility clinic setting
* Comprehensive knowledge of HFEA regulations, international quality standards, and the Code of Practice
* Experience with QMS implementation and management across multiple locations
* Strong analytical, problem-solving, leadership, and organisational skills
* Excellent communication and interpersonal skills, with proficiency in quality management software and tools
* Demonstrable presentation skills and experience in managing audits and inspections
Special Working Conditions
The post holder will have a flexible approach to the workload, which in any clinical situation can be variable. The post holder may be asked to undertake additional duties which are appropriate for their experience and duties may change/ develop over time in consultation with the Medical Director / Person Responsible
What We Offer
* A supportive, innovative and patient-focused work environment
* Training and development opportunities to expand your knowledge in fertility science and laboratory practice
* Competitive salary and benefits package