About this role
Job summary
This role is a senior member of the Welsh Blood Service Quality, Safety and Regulatory Compliance Leadership team, supporting and reporting directly to the Deputy Head of Quality, Safety and Regulatory Compliance.
As a member of the Welsh Blood Service (WBS) Quality, Safety and Regulatory Compliance Leadership Team you will lead the management and development of the divisional Quality Management System, ensuring that processes comply with all relevant legislation, regulations and accreditation standards.
You will lead the quality and regulatory oversight of change management.You will manage the process for control of critical documents and related training records. You will manage the process for recording and investigating incidents and ensure that appropriate corrective and preventative actions are in place and documented.
You will manage the Regulatory Affairs team to ensure ongoing compliance with legislation including but not limited to:
Blood Safety and Quality Legislation
Human Tissues Act
Substances of Human Origin (SoHO) legislation.
Medical Devices Regulations.
Human Medicines Regulations (as they relate to Wholesale Distribution and Advanced Therapies where appropriate)
ISO:15189, ISO:17043, and any other relevant international standards.
You will manage the WBS audit function and oversee the annual cycle of audits to ensure compliance with the above legislation and standards.
Main duties of the job
You will be able to find a full Job Description and Person Specification attached within the supporting documents or please click "Apply now" to view in Trac.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
About us
At Velindre University NHS Trust, we are proud to deliver specialist services across Wales through the Velindre Cancer Centre and Welsh Blood Service, supported by our corporate teams and partnerships with NHS Wales Shared Services Partnership and Health Technology Wales.
As we look to the future, we are preparing for the opening of the new Velindre Cancer Centre (nVCC) in Spring 2027--an exciting milestone that will transform cancer care for our population. Located within easy reach of the vibrant city of Cardiff and the stunning Brecon Beacons, we offer a unique working environment that combines innovation, collaboration and an excellent quality of life.
Since our formation in 1994, our dedicated workforce has remained committed to delivering the principles of prudent healthcare across a wide range of roles. We continue to play a vital role in our communities and have ambitious plans to further improve the services we provide.
Everything we do is underpinned by our Trust values. We arecaring,respectful, andaccountablein how we work with patients, donors, partners and each other--ensuring we deliver the highest standards of care while continuously striving to improve.
If you want to work for an organisation that makes a real difference, embraces innovation, and offers rewarding career opportunities in an inspiring setting, Velindre University NHS Trust is the place for you.
Job description Job responsibilities
You will be able to find a full Job Description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Person Specification
Experience Essential
Proven track record of managing a group of staff, and having responsibility for quality monitoring across a wider operational area where there is no line management responsibility Demonstrable experience of developing people Demonstrable experience of developing and implementing action plans in response to audit findings. Extensive experience of process management and optimisation. Extensive experience of quality systems and processes/policies in a regulated environment. Expert knowledge of Change Control and Validation procedures. Significant experience at Troubleshooting. Significant Problem-solving experience.
Qualifications and Knowledge Essential
Master's degree or equivalent professional qualification with demonstrable experience relevant to quality management. Participating in relevant CPD scheme Working knowledge of the Rules and Guidelines for Pharmaceutical Manufacturers and Distributors (orange book) Expert knowledge of the requirements of MHRA, HTA, and ISO standards Working knowledge of the UK guidelines for the Blood Transfusion Services in the UK (red book) Working knowledge of Statistical Process Monitoring IT literate in Microsoft Office and confident in learning bespoke IT systems and reporting tools.
Skills and Attributes Essential
Able to manage own workload balancing tasks and priorities. Work as team member and foster good working relationships with staff at all levels. Able to communicate with internal and external partners in a professional manner. High level of integrity and able to challenge behaviour that is not in line with trust values. Strong organisational skills. Time management and ability to prioritise. Excellent communication skills - verbal and written. Excellent organisational and inter-personnel skills. Ability to work flexibly as the role requires.
Other Desirable
Lead auditor qualification Formal Quality and/or Regulatory compliance qualification Able to demonstrate the knowledge and experience required to act as a Responsible Person for a Blood Establishment or a Pharmaceutical Wholesale Dealer Process improvement/Six Sigma Black belt qualification. Experience of working in a pharmaceutical, blood, cell or tissues environment. Experience of working with electronic quality management systems. Microsoft project/access/excel. Welsh Speaker (Level 1) or willingness to work towards
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Welsh Blood Service
Address Welsh Blood Service
Ely Valley Road
Talbot Green
CF72 9WB
United Kingdom
Employer's website https://www.welsh-blood.org.uk/ (Opens in a new tab)