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

About us

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

Job description

Job responsibilities

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

Person Specification

Royal Free World Class Values

Essential

• Demonstrable ability to meet the Trust Values

Education & professional Qualifications

Essential

• MSc or above in relevant field

Experience

Essential

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

Desirable

• Experience working with Q-Pulse
• Experience in ATMPs

Skills and aptitudes

Essential

• Strong leadership
• Strong organisational skills

Personal Qualities & attributes

Essential

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

Employer details

Employer name

Royal Free London NHS Foundation Trust

Address

Royal Free Hospital

Pond Street

London

NW3 2QG

Any attachments will be accessible after you click to apply.

391-RFL-6400008-A