Head of Quality - Radiopharmacy Remote
Job description
About the Role
We have an incredible and unique opportunity for a new Head of Quality to join our Radipharmacy team. You will need to be qualified to act as a Qualified Person in the UK to be eligible for this role and have excellent management skills.
This role is partially homebased but you will support production across 5 sites in Dinnington, Preston, Keele, Guildford and Sutton.
You will provide leadership to the Quality team at Alliance Medical Radiopharmacy, the leading manufacturer of PET Radiopharmaceuticals in the UK.
You will be responsible for the development of the Quality Assurance and Quality Control functions,to enable the delivery of first class support and QA oversight across the sites to ensure that all activities are carried out in a GMP compliant manner.
This role will provide management, integration and continuous improvement of the Quality Management Systems within Alliance Medical Radiopharmacy.
You will ensure the timely and compliant release of product to customers, in accordance with the requirements of the relevant manufacturing and marketing authorisations, so as not to cause delays in supply, by ensuring sufficient QP resources are available .
Major Accountabilities will include:
- Provide Quality leadership and direction to the Quality team.
- To harmonise site Quality Review meetings and identify and implement corrective actions to ensure quality/regulatory requirements are met across all site.
- To select, train, motivate and develop both team and individual performance using the appraisal, communication and HR systems.
- To assess current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance.
- Drive continuous improvement throughout the organization.
When required, act as a Qualified Person in accordance with the requirements of Article 51 of Directive 2001/83 EC and the code of Practice for Qualified Persons.
Please note that we will be interviewing throughout the duration of this advert. Therefore if you are interested in this role an early application is advised as we may close the advert prior to the advertised date.
Required Skills and Experience
- Qualified to Degree level or equivalent in Science and be a member of the appropriate professional body.
- Be a registered Qualified Person (Under permanent provisions in accordance with EU Directives 2001/82/EC & 2001/83/EC) and be fully conversant with MHRA regulatory requirements
- Have experience in MHRA inspections
- Have significant experience in a Quality Management role with experience as a Quality Assurance Manager in a modern manufacturing environment within the pharmaceutical industry.
- Have a comprehensive understanding of EU regulatory guidelines and the product licensing processes, GMP/GDP requirements, Quality Management systems and the principles of risk management as defined in ICH Q9 and its practical application in a manufacturing I packing environment.
About Alliance Medical
Alliance Medical are Europe’s leading independent provider of imaging services and the UK's leading manufacturer of PET pharmaceuticals.
We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years.
We live by our company values to ensure the highest level of patient care:
Our Values
Leaders, managers, and supervisors have a particular responsibility to be role models in terms of how they demonstrate these values themselves and how they engage their teams to work in this way.
Collaboration:
We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
Excellence:
We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity and respect.
Learning:
Knowledge and understanding comes from learning. At Alliance Medical we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.
Efficiency:
Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
Openness:
We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.
