A growing biotechnology company requires an experienced Quality Manager to join its team. You will ensure the business remains compliant with all legislations be responsible for the HTA licence relationship with MHRA and manage Quality systems. To be considered you must have proven experience as a Quality Manager in ISO 13485 environment and ideally with experience in HTA compliance. Due to the location of the site you must be able to drive and have your own vehicle.
Responsible for QA QC and laboratory management. The Quality Manager must ensure compliances including the EU Tissues and Cells Directive AABB cGMP GLP and ISO13485 as well as manage a stem cell processing laboratory and GMP manufacturing facility. The Quality Manager also holds the role of Designated Individual for the companies HTA licence Quality Representative for AABB and Management Representative for ISO13485.
• Oversee the Quality management system to ensure it supports all applicable regulations and standards
• Foster a site wide culture of quality and continuous improvement
• Responsible for internal and external audit programs regulatory inspections and CAPA
• Develop and direct quality improvements
• Designated lndividual for HTA license which includes:
• Quality Representative for AABB which includes:
• Management Representative for ISO13485 which includes:
• Responsible Person for MHRA which includes:
• Ensure GLP GMP HTA and 1SO13485 compliance
• Maintain and review laboratory and manufacturing procedures to ensure compliance with current legislation
• Responsible for the ongoing validation of Iaboratory and manufacturing processes machines and materials
• Supervise training and work of laboratory and manufacturing staff and critically assess for compliance
• Management of laboratory and manufacturing staff
Education and Qualifications
• Educated to degree level or equivalent in a scientific discipline;
• Relevant PhD. Desired
Skills and Knowledge
• Demonstrable cleanroom and aseptic technique;
• Excellent computer skills;
• Excellent numerical skills;
• Excellent written and verbal communication skills.
• Knowledge of HTA and EUTCD regulations
• Knowledge of GMP GLP and ISO13485 standards
• Ability to implement and maintain a quality management system that complies with EUTCD regulations and GMP GLP and ISO13485 standards
• Ability to manage a small team of technicians on a day-to-day basis;
• Ability to think clearly analyse processes and provide solutions;
• Ability to manage simultaneous tasks and prioritise accordingly;
• Ability to work under pressure;
• Ability to work both independently and as part of a team;
• Ability to interact with personnel at all levels of the company as well as agents of other companies.
• Previous laboratory experience;
• QMS design and development experience;
• Experience of training staff;
• Experience of managing staff;
• Experience of working in a cleanroom.
Salary £40k - £60k in line with experience
Job Ref: 6455