Validation Manager

Alliance Medical; Manchester; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading radiopharmaceutical company in Manchester is seeking a highly skilled Validation Manager to spearhead validation activities. The ideal candidate will have over 5 years of experience in radiopharmaceutical validation and possess a relevant degree. This role will ensure compliance with GMP standards, manage validation projects, and develop validation documentation. An early application is advised as hiring may occur before the advert closing date.

Qualifications

• 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.

Responsibilities

• Lead and coordinate validation activities across the UK Radiopharmaceutical network.
• Manage validation activities for new products/processes in compliance with GMP.
• Support Site Managers in planning and executing validation projects.

Skills

Proficient in Microsoft Word, Excel, PowerPoint, Project

Strong written and verbal communication skills

Excellent interpersonal and organisational skills

Detail-oriented, proactive, and self-motivated

Strong regulatory knowledge (GMP, Safety)

Education

Degree in a relevant scientific discipline (preferably MSc/PhD in Chemistry)

Job description

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.

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.

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.