Quality Assurance and Technical Lead

2 weeks ago

London, United Kingdom Great Ormond Street Hospital for Children NHS Foundation Trust Full time

Quality Assurance Technical Lead - Gene and Cell Therapy


An excellent opportunity has presented itself at Great Ormond Street Hospital Trust, Zayed Centre for Research into Rare Disease (ZCR) for a Quality Assurance Technical Lead in our Gene and Cell Therapy department. We are proud of being part of a well renowned national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK.


The Gene and Cell Therapy department manufactures life-saving therapies for paediatric patients under both our MHRA and HTA licences. We are expecting to soon manufacture within our new state of the art, purpose-built facility (ZCR), comprising of seven cGMP compliant laboratories and support services.


Our manufacturing facilities are licensed by the MHRA to allow us to function within the terms of our MIA(IMP) and Specials licenses.
The post holder will provide specialist technical expertise to the GOSH Qualified Person (QP) by pre-reviewing against challenging target release dates the batch manufacturing documentation for all ATIMPs manufactured by the GCT teams, identifying any issues/deviations and resolving these where possible, and where it is not possible to close them, to review the quality risk and implication to the batch with the QP as well as ensuring these are reflected in the Pharmaceutical Quality Management System. The QA Technical Lead will assist and support the QP in duties delegated to them by the QP and confirm compliance with cGMP, the GOSH MIA(IMP) and Specials licences, the IMPD, the Product Specification File and other current regulatory requirements before the review for batch certification by the QP.


This post will also provide great opportunity for the postholder to work with the Senior Manufacturing Lead Scientists to assess and kick-start new projects and support training as required of new staff recruited to work on new projects whilst ensuring compliance with agreed standards and ensuring rapid turnaround.


An individual who has a number of years of experience working in a GMP and QA environment is therefore essential for this post in order to provide the required support and guidance to our Production and QA departments and the QP.
All applicants will receive consideration for employment without regard to race, colour, national origin, religion, sexual orientation, gender, gender identity, age, disability status or length of time spent unemployed.We particularly welcome applications from BAME communities, people with disabilities and/or long-term health conditions and LGBT+ community members.We have policies and procedures in place to ensure that all applicants and employees are treated fairly and consistently. We are proud to be accredited as a Disability Confident Employer, a member of Business Disability Forum and a Stonewall Diversity Champion.We have active and Executive supported BAME, LGBT+ and Allies, Disability and Long-Term Health Conditions and Women's staff networks. Staff networks are employee-led groups formed around interests, issues and a common bond or background. Staff network members create a positive and inclusive work environment at Great Ormond Street Hospital by actively contributing to the Trust's mission, values and efforts specific to inclusion. All of our staff networks are open to any employee.
Understanding of Diversity and Inclusion challenges in the workplace.
Demonstrable contribution to advancing Equality, Diversity and Inclusion in the Workplace

Academic/Professional qualification/Training
Educated to degree level in relevant scientific discipline or equivalent
Postgraduate qualification

Regulatory requirements pertaining to ATMPs manufacture
Thorough understanding of gene and cell-based therapies
Experience of training and supervising
Experience of working in a licensed facility holding an MIA(IMP)
Proven experience of QMS management
Proven experience of risk management
Proven experience of leading investigation and root cause analysis
Proven experience of working in a QA environment

Writing and presentation of reports using computers
Training and supervision of staff
Personnel management
Project management


Great Ormond Street Hospital for Children NHS Foundation Trust
Great Ormond Street Hospital

  • Senior Software Quality Assurance

    5 days ago

    London, Greater London, United Kingdom Quality Analytics Full time

    Senior Software Quality Assurance (SQA) Architect at ReversingLabsJoin us at ReversingLabs where we provide top-notch threat intelligence solutions to safeguard software development and empower cutting-edge security solutions. We keep leading cybersecurity entities and Fortune 500 companies informed and ahead of potential threats with our software supply...

  • Quality Assurance Pharmacist

    6 days ago

    London, Greater London, United Kingdom Quality Start Full time

    Quality Assurance Night Pharmacist Northampton Opportunity: Are you a Pharmacist registered with the GPhC? Have you released drugs to prescriptions and have good quality assurance experience? Want to work for a global pharmaceutical company? If yes then please read on. Your role as a Quality Assurance Night Pharmacist based in Northampton will...

  • Quality Assurance Lead

    3 weeks ago

    London, United Kingdom Lewisham and Greenwich NHS Trust Full time

    To support the establishment and ensure implementation of the Trust’s Quality Assurance programme. To support the management of the quality assurance cycle as it relates to clinical governance, clinical audit, covering national audits and Trustwide priority audits To oversee a holistic quality assurance process, including strategic...

  • Quality Assurance Lead

    3 weeks ago

    London, United Kingdom Lewisham and Greenwich NHS Trust Full time

    To support the establishment and ensure implementation of the Trust’s Quality Assurance programme. To support the management of the quality assurance cycle as it relates to clinical governance, clinical audit, covering national audits and Trustwide priority audits To oversee a holistic quality assurance process, including strategic...

  • Quality Assurance Lead

    6 days ago

    London, Greater London, United Kingdom Lewisham and Greenwich NHS Trust Full time

    To support the establishment and ensure implementation of the Trust's QualityAssurance programme.To support the management of the quality assurance cycle as it relates to clinicalgovernance, clinical audit, covering national audits and Trustwide priority auditsTo oversee a holistic quality assurance process, including strategic standard-setting,efficient...

  • Quality Assurance Officer

    3 weeks ago

    London, United Kingdom Quality Analytics Full time

    Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in over 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service...

  • Quality Assurance Officer

    3 weeks ago

    London, United Kingdom Quality Analytics Full time

    Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in over 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service...

  • Quality Assurance Officer

    3 weeks ago

    London, United Kingdom Quality Analytics Full time

    Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in over 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service...

  • Quality Assurance Officer

    3 weeks ago

    London, United Kingdom Quality Analytics Full time

    Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader in energy storage products and services, and optimization software for renewables and storage. With a presence in over 47 markets globally, Fluence provides an ecosystem of offerings to drive the clean energy transition, including modular, scalable energy storage products, comprehensive service...

  • Quality & Assurance Lead

    6 days ago

    London, Greater London, United Kingdom QinetiQ Limited Full time

    Press Tab to Move to Skip to Content Link Job Title: PMO Quality and Assurance Lead Excellent Salary + Benefits Package Role Type: Full-time / Permanent Join us as a PMO Quality and Assurance Lead where you will have the opportunity to work with cutting-edge technology and many of the industry's most brilliant minds. The PMO Quality and Assurance Lead...

  • Quality Assurance

    4 weeks ago

    London, United Kingdom Rise Technical Recruitment Full time

    An excellent role on offer for an individual with quality assurance and regulatory experience within the medical sector looking to play a key role at an industry leading company. Do you have quality assurance and regulatory affairs experience within the medical devices sector? Would you like to work for a world leading company? Established for over 50...

  • Junior Quality Assurance Engineer

    5 days ago

    London, Greater London, United Kingdom Rise Technical Recruitment Full time

    Junior Quality Assurance Engineer 27, ,000 + Specialist Training + Progression + Excellent company benefits Addington (Commutable from: Croydon, Orpington, Biggin Hill, Halstead, Purley, Bromley) Are you from an engineering background, looking to kickstart your career for a global leading manufacturer, offering full specialist training allowing you...

  • Quality Assurance Technical Support

    2 months ago

    London, United Kingdom Eden Brown Full time

    A role of **Quality Assurance Technical Support** has come up with Camden Council for a duration of **3 months** ongoing assignment. Pay - **£25.58/hr Umbrella** Address - **5 Pancras Square, London, N1C 4AG.** JD attached **About the role**: We are seeking a highly competent individual with very good numeracy skills and a professional attitude to work to...

  • Quality Assurance Policy Lead

    7 days ago

    London, United Kingdom Marcus and Marcus ltd Full time

    We have been inspected and rated outstanding with the CQC. We are now recruiting a new and exciting role who will be working closely with the Head of Operations and General Manager, to identify development and improvement opportunities by ways of internal audits and inspections, creating action plans and working with management team to improve quality of...

  • Quality Assurance Policy Lead

    7 days ago

    London, United Kingdom Marcus and Marcus ltd Full time

    We have been inspected and rated outstanding with the CQC. We are now recruiting a new and exciting role who will be working closely with the Head of Operations and General Manager, to identify development and improvement opportunities by ways of internal audits and inspections, creating action plans and working with management team to improve quality of...

  • Quality Assurance Practice Lead

    2 months ago

    London, United Kingdom Tokio Marine HCC Full time

    **Over**view**: The QA Practice Lead will work within Product Engineering and provide a key element in driving the Target “Product Operating Model”. As we embark upon our Technology Transformation agenda, the focus on Quality Assurance is ever prevalent and the need to deliver a world class capability is as must. This is a great opportunity to build a...

  • Quality Assurance Policy Lead

    6 days ago

    London, Greater London, United Kingdom Marcus and Marcus ltd Full time

    We have been inspected and rated outstanding with the CQC. We are now recruiting a new and exciting role who will be working closely with the Head of Operations and General Manager, to identify development and improvement opportunities by ways of internal audits and inspections, creating action plans and working with management team to improve quality of...

  • Technical Assurance Engineer

    6 days ago

    London, United Kingdom Randstad Construction and Property Full time

    Are you passionate about ensuring projects adhere to the highest standards in Mechanical & Electrical services? Randstad CPE is offering an exciting opportunity for the position of M&E Technical Assurance Engineer for a prestigious client. As an essential part of the Project Delivery team, you will collaborate with Project Leaders to uphold quality processes...

  • Quality Assurance Lead

    2 months ago

    London, United Kingdom ITV Jobs Full time

    **Quality Assurance Lead** **Planet V- Advanced Advertising** **Permanent** **Office location: ITV White City** **Why you should join us** **We connect with millions of people every day, make content they can't get enough of and reflect and shape the world we live inand we do all this through the power of creativity.** **We will be a digitally led...

  • Technical Assurance Engineer

    6 days ago

    London, Greater London, United Kingdom Randstad Construction and Property Full time

    We are thrilled to announce a fantastic opportunity to join our team as an M&E Technical Assurance Engineer for a well-respected client.In this crucial position, you will collaborate closely with Project Leaders in the Project Delivery team to ensure that all projects meet the highest Mechanical & Electrical standards.Your role includes inspecting on-site...