(Senior) Clinical QA Specialist

2 weeks 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

    4 weeks ago


    Stevenage, United Kingdom BioTalent Full time

    I have an exclusive opportunity for a **Senior QA Associate** to join a pioneering biotechnology company based in **Stevenage** that focuses on developing T-cell therapies for cancer treatment. They seek a Senior QA Associate with GMP experience to support their manufacturing site and ensure compliance with regulatory requirements for clinical trial...

  • QA Specialist

    4 weeks ago


    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: We currently have an opportunity for a QA Specialists to join Autolus' growing QA function, in their QA Validation Team. The role will see you supporting the delivery of autologous CAR T-cell production in compliance with Good Manufacutring (GMP). The role is based from our Stevenage site (hybrid working between...

  • QA Specialist

    4 weeks ago


    Stevenage, United Kingdom Autolus Full time

    **Location**: - Stevenage**Job Summary**: We are currently looking for a QA Specialist to join our product delivery Quality Assurance team, supporting the delivery of autologous T-cell products in compliance with Good Manufacturing (GMP). The role will be based from our cell manufacturing site in Stevenage. This role is a site based role and you will be...

  • QA Specialist

    3 weeks ago


    Stevenage, Hertfordshire, United Kingdom Nexus Jobs Limited Full time

    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 standards and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during manufacturing and...


  • Stevenage, Hertfordshire, United Kingdom Blackfield Associates Full time

    Job Description Blackfield Associates is currently assisting a leading clinical-stage biopharmaceutical company in their search for a Senior Quality Assurance Specialist based in central Stevenage. As the Senior Quality Assurance Specialist, you will be responsible for executing QA tasks to ensure compliance with local GMP facility processes during...


  • Stevenage, United Kingdom Protech Recruitment LTD Full time

    **Life Sciences** **Medical Devices** **SENIOR QUALITY ASSURANCE OFFICER** **Industry - Pharmaceutical** **Location - Hertfordshire** **Salary - £45,000 - £50,000 DOE** Are you seeking a new challenge in the Pharmaceutical Industry? Our client is looking for an experienced Senior Quality Assurance Officer to ensure the effective performance of...

  • Clinic Coordinator

    4 weeks ago


    Stevenage, United Kingdom Hertfordshire Community NHS Trust Full time

    The ACTIVATE for CFS and Persistent Pain team sits within MSK Services providing tailored care for East and North Herts Patients. ACTIVATE for CFS and Persistent Pain is comprised of a specialist, multidisciplinary team of clinicians (including a Consultant Psychologist, Occupational Therapists and Physiotherapists), highly experienced in working with...

  • Senior Manager

    4 weeks ago


    Stevenage, Hertfordshire, United Kingdom VGS Recruitment Services Full time

    Senior Manager global Clinical Supply Chain Operations GBP90 per hour (experience dependent) + min 12-month contract with excellent possibility of permanent opportunity thereafter + immediate start available + 100% remote working + collaborative global team environment Senior Manager global Clinical Supply Chain Operations responsibilities include: ...


  • Stevenage, United Kingdom Change Grow Live Full time

    Overview: **Opportunity to set up a new IPS Services across **Hertfordshire**.** At Change Grow Live, we're not just a charity; we're a catalyst for genuine transformation in the lives of those who use our service. Driven by our values of being open, compassionate, and bold, we're dedicated to providing steadfast support and respect within a safe...


  • Stevenage, United Kingdom BMS Performance Ltd Full time

    **TERRITORY**:Midlands, South Wales, South West, South East + East Anglia - **Market leading organisation - turnover billions globally!**: - **Specialist surgical clinical training and education role**: - **Excellent opportunity for an ODP or theatre nurse!**: - **Genuine career development and progression opportunities** **THE ROLE**: As Clinical...


  • Stevenage, United Kingdom GSK Full time

    **Site Name**: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Upper Providence **Posted Date**: Feb 21 2023 **Senior Product Designer, Clinical Design, Patient Engagement & RWD** **_ Location:_**_ UK/ US_ - Come join us as we supercharge GSK’s data capability! _ - At GSK we are building a best-in-class data and prediction...


  • Stevenage, United Kingdom Albion Rye Associates Full time

    Position: Quality Assurance Manager Location: Stevenage We are working with a dynamic and innovative small to medium-sized Biotech looking for a QA Manager (GCP) to join their team. Their passionate team of scientists, clinicians, and professionals are committed to translating scientific discoveries into life-changing therapies for patients worldwide. Key...


  • Stevenage, United Kingdom Autolus Limited Full time

    Role Summary As a Senior Compute Platform Specialist/Senior IT Platform Specialist, you'll leverage your extensive expertise in Infrastructure and Networking to ensure the seamless operation of both Cloud-based and on-premise Compute environments in partnership with external collaborators. Your pivotal role involves shaping our Infrastructure Services...


  • Stevenage, Hertfordshire, United Kingdom Hertfordshire Partnership University NHS Foundation Trust Full time

    An exciting opportunity has arisen to join the Talking Therapies (formerly IAPT) teams in in a Clinical Psychology role. The Hertfordshire Talking Therapies Service is seeking to recruit a Clinical Psychologists. We currently offer hybrid working, with at least two days expected onsite for face-to-face work. This is a unique and highly valued role...


  • Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Stevenage, Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Are you interested in a leadership opportunity to bring ground-breaking cancer therapies to patients by working with a team that unites science, technology, and talent? The Clinical Scientist will report to the Clinical...


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

    Applications are invited for a Fellow in Shoulder and Elbow Surgery. This is an excellent opportunity within the Shoulder and Elbow unit at East and North Hertfordshire NHS Trust. This is a clinical and research fellowship that will provide experience in the full range of shoulder and elbow surgery, co-supervised by three consultants, Mr Adam Rumian, Mr...

  • Clinical Team Lead

    1 week ago


    Stevenage, United Kingdom Hertfordshire Community NHS Trust Full time

    We have a rare vacancy in our team for a qualified and experienced clinician who wishes to expand their leadership by managing a team of clinicians within our integrated care coordination hub this is due to expansion of the service. Hertfordshire Community Trusts (HCT) Integrated care coordination hub is the first point of contact for almost all adult...

  • Clinical Navigator

    7 days ago


    Stevenage, United Kingdom Hertfordshire Community NHS Trust Full time

    To work proactively to identify people in ED to prevent unnecessary admissions to an acute hospital bed of people who are medically fit. - To use specialist skills to assess, then plan and co-ordinate the services necessary to keep that person either at home or place in an appropriate setting. - To liaise with Drs, patient’s relatives and all involved...