Quality Manager (UK)


Zurich, Switzerland

Role

To manage and perform day to day QA activities at Cell
Medica UK based sites. Contribute to the on-going development of the Cell
Medica Pharmaceutical Quality Management System as directed by the VP Quality.

To specifically provide Quality support to manufacturing
operations based within the Cell and Gene Therapy Catapult GMP manufacturing
centre. The role will be primarily based at Stevenage (~75%) but also at other
Cell Medica sites in London (~25%).

To provide Quality support to a team, manufacturing T-cell therapy products for clinical use. The job responsibilities include Quality support to ensure compliant GMP manufacturing and testing of cell formulations, process development work for new clinical trial products and review and approval of documents including batch records, SOPs and validation/qualification plans and reports. The opportunity to be trained as a QP for AT(I)MP’s may be possible for the right candidate.

In addition to provide some general quality support to
R&D activities and clinical laboratory testing to GCLP, based at Royal Free
Hospital in London and for quality related clinical operations under GCP.

To manage the process of importation, release by the QP and
onward shipping to clinical sites in the US of clinical trial material from
Cell Medica Inc in the US.

Key Responsibilities

  • Set
    up and ensure Cell Medica activities conform with the requirements of both
    Quality Management Systems managed by Catapult and Cell Medica
  • Develop
    and manage the UK QMS
  • Perform
    routine QA duties to ensure manufacturing, testing and clinical trials
    activities comply with GMP, GCLP, GCP, HTA and other regulatory requirements
    relating to manufacture and clinical trials for cellular therapies and
    AT(I)MP's including;
  1. document
    control system for UK controlled documentation
  2. change
    controls
  3. corrective
    and preventative actions (CAPA)
  4. deviation
    & OOS reporting
  5. complaint
    and recall handling
  6. calibration
    and maintenance
  7. qualification
    & validation
  8. internal
    audits
  9. vendor
    qualification including external audits as necessary
  10. batch
    record review prior to QP release
  • Draft,
    review and approve Quality and GxP related documentation
  • Manage Product Specification Files for ATIMP’s
  • Advise
    the Cell Medica manufacturing and R&D teams on Quality related issues
  • Co-ordinate
    the import, release by the QP and dispatch of clinical trial material imported
    from the US
  • Monitor
    the effectiveness of the quality management systems for UK
  • Inform
    VP Quality and Senior Management of significant quality related matters or
    risks that could impact product quality, product release or regulatory
    compliance.
  • Promote
    quality culture with local team
  • Organize
    training of UK site personnel and deliver basic GMP training
  • Assist
    in any Quality related issue on other Cell Medica sites globally

Education and Experience

Essential

  • University
    degree in a biological science, pharmacy, chemistry or equivalent
  • 5
    years experience working in a GMP environment or equivalent experience (in
    particular small scale e.g. clinical trials or manufacturing individualised
    patient products.)
  • 3
    years experience working in a Quality related environment or equivalent
    experience.
  • Experience of writing and/or review of GxP documents (SOP’s, qualification/ validation reports and batch records) to ensure good documentation practice and essential GxP, Quality and regulatory requirements are met
  • A
    good working knowledge of EU GMP
  • A
    good working knowledge of cleanrooms, aseptic technique and hygienic
    requirements for sterile products
  • English
    Language skills
  • Good
    working knowledge of using Microsoft office programs

Desirable

  • A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • Understanding
    of QC techniques applicable to cellular products
  • Understanding
    of Immunology
  • Experience
    of monitoring the effectiveness of Quality Management Systems
  • Experience
    of electronic Quality Management Systems
  • Good
    understanding of GCP, GCLP, GDP and HTA requirements
  • Experience
    of training staff

Personal Attributes

  • Ability
    to assess risks and recommend pragmatic actions to control them
  • High
    attention to detail
  • Excellent
    interpersonal and communication skills (written and verbal)
  • 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

The job posting may be closed early if we receive a
high volume of appropriate CVs so please apply at your earliest convenience.

This
job description is subject to change at any time.


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