Director of Quality – Cell Therapies – Stevenage & London
A fantastic opportunity has arisen for a Director of Quality to join an expanding clinical stage biotechnology company headquartered in Stevenage. As an organisation they are committed to developing next generation, patient specific therapies, bringing together strong expertise across cancer evolution, bioinformatics and cellular therapy. This is a superb opportunity to join a fast-moving, innovative company who are going places, and to make a real impact in the early start-up phase.
The Director of Quality will join a growing multi-disciplinary team and support the development of a next generation personalised cancer medicines. This position will play a key role in establishing, growing and maintaining the quality systems and processes for the whole organisation across multiple sites. As part of the company management team you will be responsible for setting and reporting on key operational quality targets for the manufacture, testing and supply of advanced therapies for clinical trial. A hands-on approach is essential, and it is expected that the successful candidate will work with the clinical, regulatory and manufacturing teams to implement and develop key documentation for clinical trial applications.
*Manage day to day activities of the QA department and be the reference QA person for all company activity e.g. Document management, Change controls, Qualification & validation and Corrective and preventative actions (CAPA)
*Responsible for all QA activities, e.g. GxP (Good laboratory, clinical, manufacturing, distribution and documentation practices), company SOPs and policies, QA validation activities and compliance training
*Oversee QA for all GMP activity including batch record review to ensure that controlled documents are followed, standards of quality are maintained, and documentation is complete
*Preparing for, conducting, and responding to internal and supplier site audits. Identifying actions as a result of internal or external audits, or internal process meetings
*Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
*Organising provision of GCP and GMP training for the company.
*Oversee quality assurance planning for study related activities
*Perform review of quality metrics, CAPA findings and business process improvement opportunities, and recommending effective solutions to enhance quality and efficiency, establishing QA processes and standards and compliance related training
*Ensure systems at partners (critical raw material and service suppliers) are synchronized with current regulations, company’s expectations and quality standards.
*Raise early signals to risk of business continuity due to any quality issues. Provide direction on mitigation measures.
*Able to lead and build quality management team
To be considered for this opportunity you must be educated to MAc/PhD level in a relevant subject. This educational background will be coupled with a minimum of 10 years’ experience of working in the pharmaceutical / biotechnology field developing and maintaining quality systems. You must have extensive experience of working within a GMP environment in the field of ATMP’s and cell therapy products. Extensive knowledge of QA, CQA, QC, Regulatory Compliance and EU and US requirements for Quality Systems is required and the ability to conduct & lead audits. DI or QP experience is highly desirable.
To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on firstname.lastname@example.org
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: Lg5545_1537519476
Broadcast As: 196
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Quality Assurance
Recruitment Consultant: Lauren Gripton