Lead Quality Assurance Officer Full Time

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Please see below for detailed job description of the role.

Main duties of the job

The Lead Quality Assurance Officer plays a vital role in ensuring the safe, compliant, and high‑quality production of medicines within our Pharmacy Aseptic Services. This is an opportunity to make a meaningful impact on patient care by safeguarding the quality standards that underpin every product we manufacture.

In this role, you will contribute directly to maintaining and improving our Quality Management System (QMS), supporting day‑to‑day quality operations, and driving continuous improvement across the service. Your expertise will help ensure our teams operate in line with regulatory expectations, uphold Good Manufacturing Practice (GMP), and deliver high‑quality, timely outputs for patients and clinical teams.

You will be a key member of our multidisciplinary team, working closely with Pharmacists, Technicians, and Senior Quality Assurance Officers. Reporting to the Senior QA Officer(s), you will supervise and support QA staff, coordinate document control processes, lead investigations and audits, and contribute to quality reviews and departmental reporting. Collaboration is central to this role—you will work across pharmacy units, liaise with internal and external stakeholders, and act as a champion for quality principles throughout the service.

Working for our organisation

University Hospital Southampton is one of England’s largest acute teaching Trusts, offering a wide range of learning and development opportunities to support your career aspirations.

Located on the south coast with an international airport and direct rail links to London, Southampton offers an ideal setting to live and work, with the New Forest, South Downs and Jurassic Coast.

We believe that using technology wisely shows strong time management and commitment to innovation. However, personalizing your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.

At UHS we’re committed to providing a flexible working environment where possible. Whether you are balancing family, study, or your wellbeing with your career, we want to support you so you can help our patients.

At UHS, we proudly champion individuality, recognizing that outstanding care is only possible with a diverse, inclusive team. We’re committed to creating an anti-racist, anti-discriminatory environment where everyone feels valued, safe, and empowered to make a meaningful impact in our communities. We welcome applicants of all backgrounds, identities, and experiences to join us in building a healthcare community where everyone can belong, thrive, and contribute.

Detailed Job Description And Main Responsibilities

Lead and coordinate day‑to‑day maintenance of the Quality Management System (QMS), including document control, compliant review cycles, and version management.

Supervise and support Quality Assurance staff during daily operations, ensuring tasks are allocated effectively and staff are developed to meet service needs.

Oversee and support investigations into quality events—such as deviations, complaints, environmental monitoring excursions—and ensure CAPAs (Corrective and Preventative Actions) and deadlines are clearly defined and tracked.

Participate in internal and external audits, quality reviews, and reporting, contributing to continuous improvement across aseptic services.

The role requires participation in the Saturday morning service rota and/or the technician on‑call rota, including bank holidays.

This is a role for someone who enjoys balancing technical expertise with people leadership, thrives in a regulated environment, and is motivated by the opportunity to positively influence patient outcomes through excellence in quality assurance.

Person specification

Trust Values

Essential criteria

• Patients First
• Always Improving
• Working Together

Qualifications, Knowledge And Experience

Essential criteria

• Undergraduate degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or equivalent level of experience of GMP Quality Assurance / Quality Control.) OR Registered Pharmacy Technician in UK by GPhC OR Registered Science Technician (Apprenticeship Standard – Level 3 Diploma in the Principles of Aseptic Pharmaceuticals Processing) in UK by the Science Council
• Experience in supervising teams and ensuring high standards of performance and workflow Experience in supervising teams and ensuring high standards of performance and workflow
• Ability to work under accurately under pressure to meet deadlines while maintaining required standards.
• Experience in Good Manufacturing Practice (GMP) in relation to the production of sterile medicines
• Experience of developing and implementing Standard Operating Procedures (SOPs) and policies
• Demonstrates times when able to work effectively under pressure
• Ability to use a range of information technology programmes effectively including Microsoft office programmes
• Good organisational skills and effective time management with the ability to prioritise workload appropriately
• Ability to use initiative, but know their own limitations and professional boundaries
• Ability to work independently and as part of a multidisciplinary team
• Strong accurate communication skills in English, both verbally and in writing.
• Maintaining continuous professional development requirements or training portfolio
• Work weekends, late nights and bank holidays as per rota
• Cover flexible working hours according to rota

Desirable criteria

• Detailed knowledge of Quality Assurance and Quality Management Systems including relevant experience of audits, validation requirements, investigations, including microbiological, deviations and complaints and change management
• Experience in preparing and presenting at meetings.