Quality Assurance Manager

In this vital role, you will ensure the safety and compliance of blood and tissue provided by NHS Blood and Transplant. Every year we collect, process and issue over 2.1 million blood donations nationally, as well as carrying out research into improving the safety of blood and discovering new ways to save lives. We also provide specialist medical advice, support and training to hospitals and healthcare professionals. Joining us, you will contribute to the delivery of quality assured products that save lives every day. Managing a small team, you will proactively review and improve processes to ensure compliance. Your responsibilities will cover every aspect of quality assurance, as described, and defined by the principles of Good Practice. A key aspect of the role is the understanding and management of risk associated with planned and unplanned change that impacts on the quality and safety of products and services supplied by NHSBT. Main duties of the job In this role you will be responsible for supporting and developing NHS governance initiative and NHSBT Core purpose by assisting Director of Quality or nominee in partnership with leading functional stakeholders and project leads. Your responsibilities will include;

• Developing and maintaining compliance to all relevant licensing and accreditation standards and improve service delivery to customers for the site through site QA departments and cross-functional working.
• Acting as the Site Responsible Person (RP) under the Blood Safety and Quality Regulations and Person Designate (PD) under the Human Tissues Act (2004).
• Supporting operational Improvement events using LEAN principles and projects or workshops to identify areas for and methods to improve the services we provide.
• Identifying, managing and mitigating risks in the business to ensure a consistency in quality across the organisation.
• Providing and advising on detailed reports to stakeholders when required.
  
  MSc in transfusion/transplantation or relevant science and examination of professional body e.g. FIBMS or diploma from BBTS or BSHI, or equivalent specialist knowledge gained by experience.
• Demonstrates commitment to own continued professional development (CPD).
Experience Essential
• Specialist expert in Medicines legislation (GMP), EU Blood Directive, Tissues Directive, Organ Directive and associated Regulations, In Vitro Diagnostics Directive (CE Marking), Freedom of Information, Data Protection, Consumer Protection Act, Good Laboratory Practices (in research and clinical trials), and other mandated accreditation schemes e.g. Clinical Pathology.
• Considerable experience in a regulated (Good Manufacturing Practice, GMP) NHSBT or equivalent) environment.
• Substantial experience at senior management level and extensive experience as a senior quality professional.
• Specialist knowledge of the physiology and pharmacology of blood and tissues and their use in transfusion and transplantation.
• Knowledge of finance, purchasing, estates and statistics.
• Knowledge of HR processes, and relevant legislation.
• Specialist knowledge of Quality Control, monitoring, and diagnostic testing.
• Experience of working with information technology using Microsoft Office packages (Word, Excel an
Person Specification Qualifications Essential
• MSc in transfusion/transplantation or relevant science and examination of professional body e.g. FIBMS or diploma from BBTS or BSHI, or equivalent specialist knowledge gained by experience.
• Demonstrates commitment to own continued professional development (CPD).
Experience Essential
• Specialist expert in Medicines legislation (GMP), EU Blood Directive, Tissues Directive, Organ Directive and associated Regulations, In Vitro Diagnostics Directive (CE Marking), Freedom of Information, Data Protection, Consumer Protection Act, Good Laboratory Practices (in research and clinical trials), and other mandated accreditation schemes e.g. Clinical Pathology.
• Considerable experience in a regulated (Good Manufacturing Practice, GMP) NHSBT or equivalent) environment.
• Substantial experience at senior management level and extensive experience as a senior quality professional.
• Specialist knowledge of the physiology and pharmacology of blood and tissues and their use in transfusion and transplantation.
• Knowledge of finance, purchasing, estates and statistics.
• Knowledge of HR processes, and relevant legislation.
• Specialist knowledge of Quality Control, monitoring, and diagnostic testing.
• Experience of working with information technology using Microsoft Office packages (Word, Excel an
  
  It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, you'll join a team of more than 6,000 people who are making a genuine difference to communities, families, friends, relatives and more across the UK. We play a unique and special role in the NHS by helping people do something extraordinary- donate blood, blood products, organs, tissues, or stem cells to save someone in need. Our three core values are what set us apart. They guide and inspire everything we do. By being caring, expertly meeting the needs of our patients and our people, and accepting nothing less than the best quality, we can do extraordinary work and help our people to do something extraordinary in their career, too.
  
  A starting salary of £53,755 - £60,504 per annum in accordance with AfC.
• 2x full time permanent opportunities to join as a Band 8a, and progress with NHSBT.
• Opportunity to work with as part of regional team within a national organisation and be based in Bristol or London
• High-Cost Area Supplement (HCAS) on top of the base salary, where applicable.
• NHSBT promotes flexible working opportunities.
• 27 days annual leave (pro rata for part-time) plus Bank Holidays, increasing to 29 days after 5 years service and to 33 days after 10 years.
• NHS pension scheme. The NHS Pension Scheme is a defined benefit scheme (not dependent on investment returns) Further details and outline of benefits can be found at: www.nhsbsa.nhs.uk/pensions.
• Weve fostered a culture of continuous learning where colleagues are well-led, engaged, and encouraged to grow. We support you in reaching your full potential, both in your current role and future career. Our Thrive program embodies our commitment to learning and development, offering a wide range of activities to support your personal and professional growth. Its open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.