Quality Administrator - #2160043

At CREATE Fertility and IVI UK, we support people through one of the most important and emotional journeys of their lives.

As part of one of the world’s leading fertility groups, we combine world-class clinical expertise with genuinely compassionate care, helping thousands of patients across the UK access innovative fertility treatment tailored to them.

Our clinics are recognised for pioneering Natural and Mild IVF approaches, alongside advanced fertility services including IVF, IUI, ICSI, fertility preservation and genetic testing.

Behind every successful patient journey is an exceptional laboratory team — and exceptional leadership.

The Opportunity

The Quality Administrator provides high-level administrative and technical support to the Quality Management function, ensuring the Quality Management System (QMS) is maintained, documented, and applied consistently across the business.

The role sits close to Quality Director level, taking ownership of the day-to-day operation of the QMS and acting with a significant degree of autonomy, including final review and close-out of Subject Access Requests (SARs), so that the Quality Director can focus on strategic and escalated quality matters.

The post-holder is expected to deputise for the Quality Director on routine approvals, audits, reporting and to exercise independent judgement in applying quality standards, procedures, and regulatory requirements. The post-holder will also be trained to support the clinics' complaints function.

What You’ll Be Doing

Quality Management System (QMS)

• Support compliance with HFEA, CQC, GDPR and other applicable regulatory requirements, ensuring quality processes and records are maintained to the required standard.

• Maintain, update and control QMS documentation, including procedures, policies, standard operating procedures, work instructions, forms and registers, ensuring appropriate version control, acknowledgements and review cycles are completed.

• Support the maintenance and effective use of Quality Management Systems, including Q-Pulse or equivalent systems, ensuring records are accurate, current and auditable.

• Assist in preparing for inspections, audits and external assessments, including the collation of evidence, preparation of documentation and follow-up of agreed actions.

• Support internal audit programmes across clinical and administrative processes, including patient administration and financial processes where appropriate.

• Assist in the management and follow-up of non-conformances, corrective and preventative actions, ensuring actions are tracked to completion and escalated where required.

• Monitor compliance with QMS procedures across departments and escalate non-conformances in line with agreed protocols.

Subject Access Requests (SARs) — Final Overview

• Conduct the final quality overview of each SAR pack, verifying completeness, traceability, and conformance before submission for approval or release.

• Liaise with clinical and administrative staff to resolve queries or missing information identified during final review, without needing to refer routine cases to the Quality Director

• Maintain the SAR tracker/register, ensuring status, and approval dates are accurately recorded and auditable.

• Identify trends or recurring issues across SAR submissions and report these to the Quality Director with recommendations for supplier development or process improvement.

• Ensure approved SAR documentation is correctly shared with the data subject

• Ensure that the handling of all SAR’s is GDPR compliant

Complaints Function Support

• Support the clinics' complaints function, working in line with company policies, SOPs and regulatory requirements to help ensure formal and informal complaints are handled promptly, consistently and empathetically.

• Provide trained cover for the Complaints Manager during annual leave, absence or periods of service need, escalating complex or high-risk matters to the Quality Director and relevant senior leads as appropriate.

• Assist with the collation of statements, review of relevant records and preparation of clear, patient-focused draft responses to complaints.

• Maintain accurate complaint records, trackers and supporting documentation, ensuring statutory and internal response timescales are monitored and met wherever possible.

• Support the analysis of complaint themes, patient feedback, repeat concerns and escalation trends, contributing to quality reporting, governance reviews and continuous improvement activity.

• Liaise professionally and sensitively with patients, clinical teams, administrative teams and senior stakeholders to support effective complaint resolution and learning.

Data, Reporting & Continuous Improvement

• Compile and issue quality performance reports, KPIs and governance updates for the Quality Director and leadership team.

• Assist in monitoring quality indicators, patient feedback, clinical outcomes and service performance metrics, escalating concerns where appropriate.

• Contribute to quality reporting, KPI monitoring and governance activities, ensuring information is accurate, timely and suitable for review.

• Analyse quality data to identify trends and risks, and support continuous improvement initiatives alongside the Quality Director.

• Promote a culture of continuous improvement across all departments by supporting the identification, implementation and monitoring of service improvements.

Stakeholder & Supplier Liaison

• Act as first point of contact for quality queries from suppliers, customers, and internal departments, resolving routine matters directly and representing Quality in the Director's absence.

• Support regulatory inspections, including preparation of evidence

General Administration

• Manage the quality department's document control system and support the Quality Director with meeting minutes, management review inputs and records retention.

• Support quality and compliance training activities, including the preparation, updating and coordination of training materials.

• Assist in organising quality meetings, preparing agendas and documentation, recording actions and monitoring completion within agreed timescales.

• Support GDPR compliance and confidentiality requirements across all patient and organisational information, escalating any concerns in line with internal procedures.

Key Results / KPIs

• Maintain the Quality Management System in accordance with HFEA Code of Practice requirements, ensuring controlled documents, SOPs, forms, registers and quality records are current, accurate and inspection-ready.
• Support delivery of the internal audit programme, ensuring audits assess compliance with regulatory requirements, approved protocols and agreed quality indicators.
• Track non-conformances, incidents, audit findings and corrective and preventive actions through to timely closure, escalating overdue or high-risk actions to the Quality Director.
• Monitor quality indicators covering patient support, information provision, consent-supporting records, record keeping, confidentiality, complaints themes, incidents, training completion and audit outcomes.
• Complete final quality review of Subject Access Request packs for completeness, traceability, confidentiality and accuracy before approval or release.
• Maintain records that demonstrate compliance with HFEA, CQC, GDPR and internal QMS requirements, ensuring records are legible, retrievable, secure and protected from unauthorised amendment.
• Support inspection readiness by preparing evidence packs, maintaining action trackers and ensuring regulatory, governance and audit requests are progressed within agreed deadlines.
• Analyse quality data to identify recurring themes, risks and opportunities for improvement, supporting management review and continuous improvement activity.

Measurable Results

• At least 95% of assigned QMS documents, SOPs, forms and registers are reviewed, updated or progressed by their scheduled review date; 100% of overdue items are escalated with a documented recovery plan.
• 100% of assigned internal audits have documented scope, findings, recommendations, action owners and target dates, with records retained in an auditable format.
• At least 90% of assigned CAPA, audit and non-conformance actions are completed by the agreed due date; all overdue or high-risk actions are escalated before or on the due date.
• Monthly quality KPI reports are issued by the agreed deadline and include current status, trends, risks, overdue actions and proposed improvement actions.
• 100% of SAR tracker entries include current status, review outcome, approval date, release date and escalation status where applicable.
• Routine SAR packs are reviewed within the internal target timeframe, with complex, incomplete or high-risk cases escalated promptly to the Quality Director or relevant senior lead.
• No avoidable confidentiality breaches arise from quality administration activity; any suspected breach, data discrepancy or information governance concern is escalated immediately in line with internal procedure.
• Inspection, audit and governance evidence packs are complete, traceable and available by the agreed deadline, with all resulting actions tracked until closure.
• Training acknowledgements linked to new or revised quality procedures are monitored, with gaps reported and followed up so completion remains in line with internal compliance targets.
• Quarterly trend reviews identify recurring issues in quality records, SARs, audits, incidents, complaints themes or process compliance, resulting in documented recommendations or improvement actions where required.

Personal Qualities

We’re keen to hear from people who are:

• Calm, approachable and supportive leaders
• Passionate about delivering exceptional patient care
• Highly organised with strong attention to detail
• Collaborative and team-oriented
• Resilient and solutions-focused
• Committed to high clinical and ethical standards
• Motivated by continuous improvement and team development

Measurable Results

• At least 95% of assigned QMS documents, SOPs, forms and registers are reviewed, updated or progressed by their scheduled review date; 100% of overdue items are escalated with a documented recovery plan.
• 100% of assigned internal audits have documented scope, findings, recommendations, action owners and target dates, with records retained in an auditable format.
• At least 90% of assigned CAPA, audit and non-conformance actions are completed by the agreed due date; all overdue or high-risk actions are escalated before or on the due date.
• Monthly quality KPI reports are issued by the agreed deadline and include current status, trends, risks, overdue actions and proposed improvement actions.
• 100% of SAR tracker entries include current status, review outcome, approval date, release date and escalation status where applicable.
• Routine SAR packs are reviewed within the internal target timeframe, with complex, incomplete or high-risk cases escalated promptly to the Quality Director or relevant senior lead.
• No avoidable confidentiality breaches arise from quality administration activity; any suspected breach, data discrepancy or information governance concern is escalated immediately in line with internal procedure.
• Inspection, audit and governance evidence packs are complete, traceable and available by the agreed deadline, with all resulting actions tracked until closure.
• Training acknowledgements linked to new or revised quality procedures are monitored, with gaps reported and followed up so completion remains in line with internal compliance targets.
• Quarterly trend reviews identify recurring issues in quality records, SARs, audits, incidents, complaints themes or process compliance, resulting in documented recommendations or improvement actions where required.

Qualifications

• Educated to A-Level / equivalent standard as a minimum; a relevant quality qualification (e.g. IQA Certificate/Diploma in Quality, Lean Six Sigma Green Belt) is desirable.

• Internal auditor qualification is desirable

• Experience within the Fertility Sector is desirable

Experience / Personal Specification

Experience

• Proven experience in a quality administration, quality compliance or quality assurance role within a regulated or process-driven manufacturing/engineering environment.

• Demonstrable experience reviewing and approving Subject Access Requests (SARs)

• Experience supporting or leading internal/external audits and managing corrective action processes.

• Experience deputising for, or working closely alongside, a senior quality professional.

• Experience supporting complaint handling, patient feedback processes or sensitive customer/patient communication is desirable; the post-holder will be trained to provide complaints-function cover to the required internal standard.

Skills & Attributes

• Strong working knowledge of HFEA regulations

• Excellent attention to detail and ability to make sound, independent judgements.

• Strong organisational skills with the ability to manage multiple concurrent reviews and deadlines.

• Confident communicator, able to challenge suppliers and internal stakeholders professionally to resolve non-conformances.

• Proficient in Microsoft Office (Excel, Word, PowerPoint) and quality/ERP systems (e.g.Q-Pulse).

• Able to work with a high degree of autonomy while knowing when to escalate to the Quality Director.

• Able to communicate with empathy, clarity and professionalism when supporting patients and colleagues through complaint or concern resolution processes.

Key Relationships

• Internal: Quality Director, Complaints Manager, Persons Responsible, Clinic Managers, Operations Director, Medical Director and Nursing Director.

• External: Suppliers, customers, certification bodies, and regulatory auditors.

Scope & Level of Authority

This role operates at a level just below Quality Director, with delegated authority to give final sign-off on SARs and routine quality documentation., and to provide trained cover for defined complaints-function activities during the Complaints Manager's annual leave, absence or periods of service need.

Decisions involving significant patient complaint escalations, regulatory non-compliance, reputational risk, safeguarding concerns or QMS policy changes remain the responsibility of the Quality Director and relevant senior leads, to whom the post-holder reports and regularly liaises.