Job Title: Quality Manager (UK), Cell Medica Ltd

Responsible To: Vice President, Quality

Responsible For: Currently no direct line management


To manage and
perform day to day QA activities at Cell Medica UK based sites.

Contribute to establishing
a Pharmaceutical Quality System (PQS) to enable compliant manufacture and
testing of Advanced Therapeutic Medical Products within the Cell and Gene
Therapy Catapult GMP manufacturing centre as directed by the VP Quality.

To provide
Quality support to manufacturing operations, manufacturing Cell therapy products
for clinical use based within the Cell and Gene Therapy Catapult (CGTC) GMP
manufacturing centre. The job responsibilities include Quality support for process
development work for new clinical trial products and review and approval of documents
including batch records, SOPs and validation/qualification plans and reports.

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.

The role is primarily
based at Stevenage (~75%) but also other Cell Medica sites in London (~25%).


Ensure Cell Medica quality activities conform
with the requirements of both Pharmaceutical Quality Systems managed by CGTC
and Cell Medica

Point of contact for Quality related activities as
required by Quality Technical Agreements with contract partners in particularly

Development of the Cell Medica PQS

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)MPs including;

document control system

change controls

corrective and preventative actions (CAPA)

deviation & OOS reporting

complaint and recall handling

calibration and maintenance

qualification & validation

internal audits

vendor qualification including external audits as

batch record review prior to QP release

Draft, review and approve Quality and GxP related

Assume role of company archivist and liaison with
off-site archive company

Manage Product Specification Files for ATIMPs

Advise the Cell Medica manufacturing and R&D
teams on Quality related issues

To trend and report trends on performance of the

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


University degree in a biological science, pharmacy,
chemistry or equivalent

Min 8 years experience or equivalent experience working in a GMP environment (in particular small scale e.g. clinical trials or manufacturing individualised patient products.)

Min 5 years experience or equivalent experience working in a Quality related environment

Experience of writing and/or review of GxP documents (SOPs, 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


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

Good understanding of GCP, GCLP, GDP and HTA

Experience of training staff


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

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