(Senior) Clinical QA Specialist

8 months ago

Stevenage, United Kingdom Autolus Ltd Full time

**Location**:

- StevenageThe (Senior) Clinical Quality Assurance Specialist is responsible for quality oversight activities within Clinical development by supporting and managing cross-functional relationships with business process owners and external stakeholders. Maintains Quality Assurance oversight in Clinical Operations and Clinical Development. This is a high visibility position in the organisation with great impact potential and huge development opportunities. In addition, the role also supports compliance of the Autolus quality management system.

The role is key within the overall Quality organisation at Autolus and ensures that the company remains compliant with GCP / GVP regulations, including activities supporting clinical trials involving ATIMPs. This role encompasses oversight and support of quality system types including paper, electronic or hybrid. Reporting to the Director, GCP QA, the job’s reach spans across several manufacturing sites plus multiple clinical trials.

Key Responsibilities
- Support the development and implementation of the risk-based audit plan for GCP/GVP-regulated activities.
- Support the planning, conduct and follow-up activities of audits for vendors, contract research organizations (CROs), clinical investigator sites, trial master file, and internal business processes within clinical development and operations.
- Provide QA support to Clinical project teams.
- Support the development and maintenance of the quality management system in conjunction with the Quality team and other stakeholders.
- Manage, review, and approve quality events, including deviations, investigations, and corrective and preventive actions pertaining to the GCP/GVP area.
- Authoring, review, and approval of Clinical QA and GxP procedural documents - In collaboration with relevant stakeholders develop, implement, maintain, and improve policies, procedures, and associated plans for Clinical QA.
- Promote Good Documentation Practice within clinical project functional areas.
- Support the administration of the Trial Master File TMF system (including but not limited to user management, configuration, and validation).
- Administration management of all relevant eQMS systems used at Autolus within a GCP environment to ensure they are managed in a controlled, traceable, and auditable manner and ensure the principles of data integrity are upheld.
- Collaborate with stakeholders to identify process gaps and recommend solutions.
- Provide GCP/GVP metrics on compliance and present at quality review meetings and/or functional meetings.
- Assist with regulatory inspections e.g., MHRA, FDA, EMA etc Including inspection co-ordination activities.
- Support clinical inspection readiness activities.

  • Senior QA Engineer

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Mane Contract Services Full time

    Job TitleSenior QA EngineerWe are seeking a Senior QA Engineer to join our team at Mane Contract Services. The successful candidate will be responsible for ensuring compliance with customer requirements while supporting production ramp-up.The estimated salary for this role is £55,000 (Up to) based on industry standards and the location in Stevenage....

  • QA Specialist with GMP

    4 weeks ago

    Stevenage, United Kingdom Nexus Jobs Limited Full time

    Job Description QA Specialist - Project Support - 12 month Fixed Term Contract Our Client is looking to recruit a QA Specialist with at least 5 to 10 years expertise within a clinical environment. Reporting to and with the guidance of the Head of Quality Assurance, this role will ensure that the manufacturing centre, via proactive engagement, meets the...

  • QA Associate

    3 days ago

    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: The QA Associate will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. You will be expected to work...

  • QA Associate

    3 days ago

    Stevenage, United Kingdom Autolus Ltd Full time

    The QA Associate will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. You will be expected to work with a team of quality professionals to...

  • QA Associate

    7 months ago

    Stevenage, United Kingdom Autolus Ltd Full time

    Based in Stevenage, the post-holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to work with a team of quality professionals to...

  • QA Associate

    7 months ago

    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: Based in Stevenage, the post-holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to...

  • IT Service Desk Engineer Apprentice

    3 days ago

    Stevenage, United Kingdom QA Ltd Full time

    **Employer description**: Primenet UK are a Managed Services Provider and trusted IT solutions company. They offer a range of trusted IT services, from support to security to maintenance — well known for their customer service as well as their IT services. **Overview:** You will have the opportunity to gain valuable skills, knowledge and experience as...

  • Senior QA Officer Pharmaceutical Manufacturing

    2 weeks ago

    Stevenage, Hertfordshire, United Kingdom Russell Taylor Group Ltd Full time

    **Job Overview**We are seeking a highly skilled QA Officer or Senior QA Officer to join our team at Russell Taylor Group Ltd in Stevenage. This exciting opportunity will allow you to contribute to the development of our QMS and drive positive change within the quality management system.Key Job Description:Ensure the quality of pharmaceutical products meets...

  • QA Officer, Pharmaceutical

    1 month ago

    Stevenage, United Kingdom CV-Library Full time

    QA Officer/Senior QA Officer, Pharmaceutical Location: Stevenage Type: Permanent Salary: £35000 - £45000 depending on experience Russell Taylor Group is working exclusively with an established pharmaceutical manufacturing company who is looking to recruit for an experienced QA Officer or a Senior QA Officer (depending on experience) to work as...

  • Quality Assurance

    7 days ago

    Stevenage, United Kingdom Autolus Ltd Full time

    The post holder will work in the Quality Assurance Operations team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK and EU from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. Please note this role is based from our Stevenage site and due to the...

  • Quality Assurance

    7 days ago

    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: The post holder will work in the Quality Assurance Operations team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK and EU from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. Please note this role is...

  • Electronic QA Specialist

    6 days ago

    Stevenage, Hertfordshire, United Kingdom MBDA UK Ltd Full time

    Job OverviewWe are seeking a skilled Electronic QA Engineer to join our Product Assurance Equipment Engineering team. This role offers an exciting opportunity to support the development of electronic equipment and ensure high-quality standards are met.

  • Clinical Pharmacy Specialist

    6 days ago

    Stevenage, Hertfordshire, United Kingdom NHS Full time

    About the RoleAs a clinical pharmacy specialist, you will play a vital part in our award-winning pharmacy team. We are seeking highly motivated pharmacists to join our innovative and patient-centred department, supporting their growth into outstanding clinical pharmacists.We offer a structured rotational program that includes specialities such as ED, acute...

  • Quality Assurance

    6 days ago

    Stevenage, United Kingdom Autolus Ltd Full time

    The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products for clinical trials operating in sites across the UK and EU from a central Good Manufacturing (GMP) site in Stevenage (UK) and headquarters in White City, London. Please note this role is working Monday to Friday, 9am to 5pm...

  • Senior Clinical Fellow in RHeumatology

    7 months ago

    Stevenage, United Kingdom East and North Hertfordshire NHS Trust Full time

    We have 1 fixed term appointment available for 6 months for a Senior Clinical Fellow in Rheumatology based at Lister Hospital in Stevenage. This is an excellent opportunity within the Rheumatology department at East and North Hertfordshire NHS Trust. The appointee would be an active member of the Department of Rheumatology, participating in weekly...

  • Senior Clinical Scientist

    3 weeks ago

    Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Job SummaryWe are looking for an experienced Senior Clinical Scientist to join our team at GlaxoSmithKline (GSK). As a key member of our oncology development team, you will be responsible for leading the implementation of effective clinical strategies for GSK's oncology pipeline.The ideal candidate will have a strong background in clinical development, with...

  • Principal Clinical Programming Specialist

    6 days ago

    Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    About the Position:">GlaxoSmithKline (GSK) is seeking an experienced Principal Clinical Programming Specialist to join our team in the Clinical Programming department. As a Principal Clinical Programming Specialist, you will be responsible for leading cross-functional teams to design and implement clinical trial programs, developing statistical models, and...

  • Senior Clinical Fellow in Trauma

    10 hours ago

    Stevenage, United Kingdom East and North Hertfordshire NHS Trust Full time

    Applications are invited for a Senior Clinical Fellow in Trauma and Orthopaedics. This is a fixed term appointment for a period of 12 months. The post is based at Lister Hospital in Stevenage, is full time and the post holder will be expected to participate on the 1:14 to 1:18 rota commitment. This is an excellent opportunity within the Trauma and...

  • Clinical Care Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Nhs Professionals Limited Full time

    Are you a dedicated and skilled Registered Nurse looking for a new challenge? NHS Professionals Limited is seeking an experienced Clinical Care Specialist to join our team in the East and North Hertfordshire NHS Foundation Trust. In this role, you will have the opportunity to work with a variety of patients and provide high-quality care in a dynamic and...

  • Senior Clinical Radiology Department Assistant

    6 months ago

    Stevenage, United Kingdom East and North Hertfordshire NHS Trust Full time

    We are recruiting for a Senior Clinical Radiology Department Assistant who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients. The post is based at Lister Hospital, but the post holder will be expected to rotate to the New QEII Hospital and cover occasional shifts at Hertford County Hospital as...