Head of Quality Control – ATMPs / Cell Gene Therapy - London
A superb opportunity has arisen for a Head of GMP Quality Control to join a world- leading clinical organisation based in London. This is a fantastic opportunity to work with a multitude of different products and collaborate with top academic & biopharma institutions.
Reporting into the Director of the facility the Head of Quality Control will be responsible for:
- - Establishment of a new QC laboratory, to validate existing and new analytical equipment and design and validate new QC assays.
- - Directly line manage a team and train members in all aspects of QC
- - QC lab budget management- ensure that the Quality Control Service is adequately staffed and resourced
- - Perform vendor assurance and critical supplier auditing
- - Development and validation of all new ATMP manufacturing procedures
- - Creation of all batch manufacturing records
- - Contribute to the formulation of patient specific ATMP medicines in response to their individual clinical needs
- - Review all regulatory agency submission materials
- - Participate in the development of regulatory strategies and implementation plans for the preparation and submission of new products.
- - Educated to minimum of MSc level in a relevant field
- - Strong experience in cell and gene therapy / ATMPs quality control
- - Ex-vivo culture of human stem cells, multiparametric flow cytometry desirable
- - Previous leadership experience
- - Holder of QP status or within training for QP status is desirable- the company are keen to support candidates through QP applications
In return you can expect to receive a competitive salary, excellent pension scheme and extended holiday allowance. Please do not hesitate to contact Lauren Gripton at firstname.lastname@example.org / + 44 (0) 121 616 3465
Keywords- QC, quality control, QA, quality assurance, regulatory, Bsc, Msc, PhD, cell therapy, cellular therapies, gene therapy, Advanced therapy medicinal products,
Investigational Medicinal Products, manager, head, principal, group leader, qualified person, CAR-T.