Manager Quality Control - Cell therapy - London

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.  

Requirements

• - 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 lgripton@pararecruit.com / + 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.