Job summary
- Main area
- Vector Quality Assurance Manager - Centre for Cell Gene and Tissue Therapeutics (CCGTT)
- Grade
- NHS AfC: Band 8a
- Contract
- Fixed term: 12 months (With probable extension to 24 months and substantiation based on achievement of vector lab KPIs.)
- Hours
- Full time - 37.5 hours per week
- Job ref
- 391-RFL-6400008
- Employer
- Royal Free London NHS Foundation Trust
- Employer type
- NHS
- Site
- Royal Free Hospital
- Town
- London
- Salary
- £58,698 - £65,095 Per annum inclusive of HCAS
- Salary period
- Yearly
- Closing
- 19/07/2024 23:59
Employer heading
![NHS](https://static.trac.jobs/emptype/nhs.gif)
Band 8A Vector Quality Assurance Manager
NHS AfC: Band 8a
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.
Click here to view our video Welcome to the Royal Free
Click on the logo below to see the video of the Royal Free London NHS Foundation Trust values
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
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
Further details / informal visits contact
- Name
- Owen Bain
- Job title
- Director/QP
- Email address
- [email protected]
If you have problems applying, contact
- Address
-
Recruitment Support
Open Monday to Friday
08:30 am to 17:30pm
- Telephone
- 01629 702338
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