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

Responsible To: Vice President, Quality

Responsible For: Currently no direct line management

Role

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%).

Key
Responsibilities


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
CGTC


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
necessary


batch record review prior to QP release


Draft, review and approve Quality and GxP related
documentation


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
PQS


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


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
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


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