Band 8A Vector Quality Assurance Manager

Job title:

Band 8A Vector Quality Assurance Manager

Company

NHS

Job description

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 jobWe 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 QMSAbout usRoyal Free World Class ValuesThe 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

Date posted06 September 2024Pay schemeAgenda for changeBandBand 8aSalary£58,698 to £65,095 a year Per annum inclusive of HCASContractPermanentWorking patternFull-timeReference number391-RFL-6400008-AJob locationsRoyal Free HospitalPond StreetLondonNW3 2QGJob descriptionJob responsibilitiesPlease see the attached job description and person specification for detailed job description and responsibilities. Job descriptionJob responsibilitiesPlease see the attached job description and person specification for detailed job description and responsibilities.Person SpecificationRoyal Free World Class ValuesEssential

• Demonstrable ability to meet the Trust Values

Education & professional QualificationsEssential

• MSc or above in relevant field

ExperienceEssential

• 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 aptitudesEssential

• Strong leadership
• Strong organisational skills

Personal Qualities & attributesEssential

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

Person SpecificationRoyal Free World Class ValuesEssential

• Demonstrable ability to meet the Trust Values

Education & professional QualificationsEssential

• MSc or above in relevant field

ExperienceEssential

• 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 aptitudesEssential

• Strong leadership
• Strong organisational skills

Personal Qualities & attributesEssential

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

Expected salary

£58698 – 65095 per year

Location

North West London

Job date

Sun, 08 Sep 2024 06:28:18 GMT

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