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QA Manager

Location: Stevenage

ABOUT US

At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

 

OUR COMPANY

Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £59M with a further £2M contributed by UCL Technology Fund.

 

THE ROLE

QA Manager

Quell therapeutics is looking to recruit an experienced Quality Assurance Manager to manage and perform day to day QA activities at Quell manufacturing site based in Stevenage, UK. The role will require the successful candidate to lead establishing a risk based Pharmaceutical Quality System (PQS) to enable compliant manufacture and testing of Advanced Therapeutic Medical Products as directed by the Senior Director, QA. They will help build and then manage a small team of QA professionals.

 

MAIN RESPONSIBILITIES

  • To provide Quality support to manufacturing operations and quality control, manufacturing and testing cell therapy products for clinical use based within a shared GMP manufacturing centre
  • Manage and perform routine QA duties to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including
    • Document control system
    • Training system
    • Change controls
    • Corrective and preventative actions (CAPA)
    • Deviation & OOS reporting
    • Complaint and recall handling
    • Calibration and maintenance
    • Qualification & validation
    • Internal audits
    • Vendor qualification
    • Batch record review prior to QP release
  • Act as the point of contact for Quality related activities as required by Quality Technical Agreements with contract partners
  • Draft, review and approve Quality and GxP related documentation
  • Facilitate or perform risk assessment and investigations as required
  • Manage Product Specification Files for ATIMP’s
  • Advise the Quell manufacturing and QC teams on Quality related issues
  • Advise and assess the quality and suitability of equipment, materials and services for their intended purpose. Perform external audits as necessary.
  • Monitor for trends and the effectiveness of the quality management systems including developing and producing KPI’s and Quality Metrics
  • Inform Head of Quality and Senior Management of significant quality related matters or risks that could impact product quality, product release or regulatory compliance.
  • Recruit, manage and develop QA team to meet needs of business
  • Promote quality culture and one of continuous improvement within team
  • Organize and deliver QA related training and deliver basic GMP training
  • Provide general quality support for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required

 

TECHNICAL SKILLS REQUIRED

  • University degree in a biological science, pharmacy, chemistry or equivalent
  • Min 8 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
  • Some experience with supporting the manufacture of ATMP’s
  • Experience of writing and/or review of GxP documents (including SOPs, qualification/ validation reports and batch records) to ensure good documentation , data integrity, GxP, quality and regulatory requirements are met
  • Experience of leading or facilitating investigations including root cause analysis
  • Experience of auditing
  • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
  • A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • Demonstrated experience in developing a PQS especially involving an eQMS
  • Exemplary attention to detail and record keeping demonstrating good documentation practices
  • Excellent interpersonal and English language communication skills (written and verbal)
  • Capable of managing a wide range of tasks, managing own time effectively and prioritising tasks for self and team accordingly
  • Experience of managing and developing staff within a small team
  • Ability to work with integrity, to high ethical standards with an open-minded pragmatic approach

 

DESIRABLES

  • A working knowledge of Tissues and Cells Directive and HTA requirement
  • Experience of monitoring the effectiveness of Quality Management Systems
  • Experience of electronic Quality Management Systems
  • Good understanding of GCP, GCLP, GDP and HTA requirements
  • Lead auditor trained
  • Understanding of QC techniques applicable to cellular products
  • Understanding of Immunology
  • Experience of training staff

 

PERSONAL QUALITIES

  • Ability to assess risks and recommend pragmatic actions to control them
  • High attention to detail
  • Excellent interpersonal and communication skills (written and verbal)
  • Able to lead by example and diplomatically persuade others
  • Capable of managing a wide range of tasks with minimal direction and prioritising tasks accordingly
  • Highly self-motivated and able to motivate others
  • Pleasant manner, open minded, honest

 

BENEFITS

  • Holidays: 25 days per year
  • Life Assurance: 4 x base salary
  • Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
  • Private Medical Insurance for your whole family
  • Annual Bonus

 

PERKS

  • Fantastic collaborative environment at Translation & Innovation Hub
  • £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
  • Flexible working
  • Fast paced and progressive company looking for future leaders and innovators.

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