Lead Quality Specialist

2 months ago

Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom NHS Blood and Transplant Full time
About the Role

We are seeking a highly experienced and skilled Quality Assurance Manager to join our team at NHS Blood and Transplant. As a key member of our Quality senior management team, you will play a critical role in developing, implementing, and monitoring an effective quality management system (QMS) that ensures the highest standards of quality and safety in our products and services.

Key Responsibilities
  • Provide visible senior leadership and oversight of the quality and safety agenda, collaborating with stakeholders to drive real improvements for patient and donor safety.
  • Lead portfolios or key programs of work, supporting quality management, improvement, and safety system approaches as designated.
  • Provide line management of staff, teams, or functions within a portfolio or across a matrix.
  • Ensure safety compliance and regulatory expertise is provided to operational areas for business-as-usual activities and new service development.
  • Take ownership and accountability for the status of the QMS, ensuring it is maintained and developed to meet the needs of the organization.
  • Develop, implement, monitor, and improve the necessary quality expertise and systems required to deliver an efficient and effective QMS and GMP system.
  • Support the Assistant Director of Quality and Regulatory Compliance in developing and delivering a Quality Strategy that aligns with NHSBT's safety focus.
About Us

NHS Blood and Transplant is a unique and special organization that plays a critical role in the NHS. We are a team of over 6,000 people who are passionate about making a difference in the lives of patients and donors across the UK. Our three core values - Caring, Expert, and Quality - guide everything we do, and we are committed to delivering the highest standards of quality and safety in our products and services.

Requirements
  • Masters in a bio-medical or pharmaceutical subject with examination via professional body, or extensive relevant experience to masters level.
  • Demonstrates commitment to ongoing professional development (CPD).
  • Significant experience of leading a quality and improvement team.
  • Experience of co-production with stakeholders-service users.
  • Substantial project management, performance management, strategic planning, and risk identification and management experience.
  • Experience of leading and implementing significant change projects-programmes.
  • Proven record of developing and maintaining an effective QMS and information resources to drive innovation within a service.
  • Experience of working with minimal supervision, working alone and within a team-amongst teams.
  • Substantial experience as a senior quality professional in a regulated (Good Pharmaceutical Manufacturing Practice, NHSBT or equivalent) environment.
  • Working knowledge of relevant legislation and components of quality, safety, risk, governance, and assurance functions.
  • Experience of coaching colleagues to take responsibility for their own development and work through self and group accountability, varied assignments, and ongoing feedback.
  • Working knowledge of Freedom of Information, EU General Data Protection Regulation (UK Data Protection Act), Good Automated Manufacturing Practice, and related legislation.
  • Specialist knowledge of the physiology and pharmacology of blood and tissues and their use in transfusion and transplantation.

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