Validation Manager

About The Role

We are seeking a highly skilled and motivated Validation Manager to lead and coordinate validation activities across our UK Radiopharmaceutical (RP) network.

This pivotal role will support the introduction of new products and processes, ensuring compliance with GMP and regulatory standards.

The successful candidate will work closely with Site Managers, the Head of Operations, and the Northern Europe team to streamline validation efforts and drive technical excellence across the network.

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.

Duties And Responsibilities

General Responsibilities:

• Collaborate with the Head of Operations RP UK and Programme Manager to deliver validation activities across the UK RP network.
• Support Site Managers in planning and executing validation projects.
• Ensure appropriate staffing and provide training to support validation tasks.
• Coordinate with the Northern Europe team to streamline validation and introduce new products.
• Deliver technical training on new processes.

Role-Specific Responsibilities:

 Validation

• Manage validation activities for new products/processes in compliance with GMP and pharmacopeia standards.
• Oversee the validation lifecycle and support regulatory submissions and audits.
• Generate validation documentation (VMP, URS, DQ, IQ, OQ, PQ, PV).
• Create RQ protocols for new equipment/processes.
• Understand and manage RMS approval procedures and supplier additions.
• Travel routinely across RPUs to support validation activities and share best practices.

 Staff

• Establish rotas and dedicated project teams for validation.
• Supervise production staff to ensure resources meet validation needs.
• Support staff training and development aligned with individual objectives.

Maintenance

• Develop schedules for calibration, maintenance, and qualification of new equipment/processes.
• Collaborate with OEM engineers to create training plans.
• Participate in supplier training to stay updated on best practices.

Faults

• Work with Site & Engineering Managers to manage faults during validation.
• Maintain logs for troubleshooting and GMP compliance.
• Diagnose and rectify operational faults, escalating when necessary.

5. Quality Systems

• Assist in developing and managing cGMP and Quality Assurance systems for radiopharmaceutical production.

Aseptic Training

• Maintain production training to support validation activities.
• Complete media fill training as required.

Chemicals

• Manage chemical stock, preparation, safe storage, and disposal for validation projects.

Standard Operating Procedures

• Prepare and update SOPs in line with relevant guidelines.

Training

• Attend conferences/workshops to stay current with best practices.
• Provide hands-on validation training and development plans for staff.
• Complete annual GMP, Pharmacovigilance, Radiation, PrOFS, and mandatory eLearning training.

R&D

• Collaborate with operational and project teams to develop and introduce new products.

Skills in Radiochemistry

• Operate cyclotron and produce radioisotopes.
• Synthesize radiolabelled PET tracers.
• Follow clean room protocols for aseptic/sterile dispensing.

Safety and Control

• Undertake Radiation Protection Supervisor (RPS) training.
• Follow site radiation safety rules and health & safety procedures.
• Liaise with RPA and DGSA to ensure regulatory compliance.

Regulatory

• Support regulatory submissions and act as SME during audits.
• Adhere to GMP, GLP, and safety protocols from MHRA, EA, HSE/ONR.

About Alliance Medical

Alliance Medical are Europe’s leading independent provider of imaging services.

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.

Skills and Experience

Minimum Qualifications:

• Degree in a relevant scientific discipline (preferably MSc/PhD in Chemistry due to the complexity of radiopharmaceutical development).

Previous Experience:

• Minimum 5 years’ experience in product and process validation within a radiopharmaceutical setting.
• Proven managerial or supervisory experience with successful project delivery.
• Demonstrated ability to develop staff in validation practices.

Skills and Attributes:

• Proficient in Microsoft Word, Excel, PowerPoint, Project.
• Strong written and verbal communication skills.
• Familiarity with PrOFS and product ordering systems.
• Excellent interpersonal and organisational skills.
• Detail-oriented, proactive, and self-motivated.
• Strong regulatory knowledge (GMP, Safety).
• Ability to lead by example and work independently.