Band 8A Vector Quality Assurance Manager

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Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This larger scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients.

Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research and we will continue to measure our progress against our five governing objectives: excellent outcomes, excellent patient and staff experience, excellent value for taxpayers' money, being safe and meeting our external duties, and building a strong organisation.

Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.

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Job overview

An excellent opportunity has presented itself at the Centre For Cell, Gene and Tissue Therapeutics at the Royal Free Hospital. We are one of the most productive academic units of it's kind in the UK, manufacturing ATMPs across from spectrum from CAR-Ts to hESCs for early stage clinical trials supplying the UK, the EU and US.

This is a newly created postdoctoral position within the Centre for Cell, Gene & Tissue Therapeutics.

trials.

The post holder will be the Vector Quality Assurance Manager for the implementation and ongoing support of the viral vector manufacturing facility. They will also oversee the training programme, participate in audits and inspections. In addition, the postholder will support supplier qualification and documentation activities for the core facility.

Main duties of the job

We are looking for a highly motivated individual who has a strong understanding of QA, GMP principles, and regulatory requirements. They will possess excellent communication, organisational, and leadership skills. The QA Manager will collaborate with various stakeholders, including the Director of Vector, GMP Production staff and clinical leads. This role is crucial in maintaining a culture of quality and excellence within the department, and the manager will play a pivotal role in ensuring that all Quality activities meet the highest standards of compliance and efficiency.

The post holder will be responsible for ensuring that the laboratory is compliant with current legislation and best practice and be a central member of the management team during statutory regulatory inspections by MHRA.

The post holder will ensure the delivery of a high quality service to all users of the CCGTT.
Core duties include:

- Implementation of QMS and GMP for viral vector facility for vector as a critical starting material for internal and external ex-vivo use.

- Establish and Maintain a training programme and management of GMP staff

- Management and monitoring of the QMS

- Management of the change control, non conformance, risk assessment and audit

- Leading deviation investigations and root cause analysis

- Approval and control of documentation for the core facility

- Administrator for Q-Pulse QMS

Working for our organisation

Royal Free World Class Values

The post holder will offer World Class Care to service users, staff, colleagues, clients and patients alike so that everyone at the Royal Free can feel:

• Welcome all of the time
• Conident becuase we are clearly communicating
• Respected and cared for
• Reassured that they are always in safe hands

Detailed job description and main responsibilities

Please see the attached job description and person specification for detailed job description and responsibilities.

Person specification

Royal Free World Class Values

Essential criteria

• Demonstrable ability to meet the Trust Values

Education & professional Qualifications

Essential criteria

• MSc or above in relevant field

Experience

Essential criteria

• Minimum of three years' experience in Quality Assurance
• Thorough understanding of Good Manufacturing Practice

Desirable criteria

• Experience working with Q-Pulse
• Experience in ATMPs

Skills and aptitudes

Essential criteria

• Strong leadership
• Strong organisational skills

Personal Qualities & attributes

Essential criteria

• Ability to work independently and as part of a team
• Self motivated

• Covid-19 Vaccination

  Getting vaccinated, and getting a booster, remains the best defence against COVID-19.
  We encourage and support staff to get COVID-19 vaccine and a booster dose as and when they are eligible.

• AT* - Apprenticeship Training. Where AT* is entered next to the job title indicates that this vacancy is for an apprenticeship role.
• By applying for this role, you accept if successful, that your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which aims at saving you time and improving efficiencies within the NHS when your employment transfers. Therefore we require you to complete your stat and Man e-learning modules prior to joining our organisation.
• If you are an EU/EEA citizen who does not have EU Settlement or Pre-Settled status, you will require a visa to work in the UK.
• Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. Before submitting your application and to avoid disappointment please check that you are eligible under the UKVI points based system.
• If you are offered a role with one of the NLPSS partner trusts, as part of pre-employment checks your identity and right to work documentation will be verified remotely (in most circumstances), using a certified identity verification service provider TrustID. You will be asked to capture an image of the relevant documents as well as a "selfie" using your smartphone/tablet (if available) for facial matching. TrustID will also perform a digital address check using Trunarrative and Equifax, which is a soft check and does not leave a footprint on your credit rating. For more information, visit www.trustid.co.uk
• The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.
• The Trust will request a DBS (CRB) if post involves regulated activities. The Trust is compliant with the Disclosure and Barring Service Codes of practice and the Rehabilitation of offenders act.
• By applying for this post you are agreeing to Royal Free London NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system.
• Please be aware of scams - unless specified above, we will only communicate with you via @recruit.trac.jobs or nhs.net e-mails and we will never ask you for any payments.

Applications are welcome from people wishing to job share or work flexible patterns. We are committed to equal opportunities.

Please note:

• Due to the high number of applications that are received for some posts we may close this vacancy before the advertised closing date. Therefore please apply for this post as soon as you can, if you are interested and you meet the requirements of the Person Specification
• Only those candidates who clearly demonstrate how they meet the person specification will be shortlisted for this job.
• Interview arrangements will be communicated via email so please check your email regularly following the closing date.

Please be advised that due to exceptionally high demand, all Royal Free accommodation is at full capacity and waiting lists are being held. Average waiting times are 12 months. Please do not rely on Trust accommodation when you commence your role and ensure you investigate alternative accommodation for your arrival.

Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• JD Vector QA Manager (PDF, 528.3KB)
• PERSON SPECIFICATION Vector QA Manager (PDF, 56.7KB)
• Functional requirements (PDF, 24.7KB)