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Validation Manager

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Alliance Medical Ltd

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Location:
United Kingdom , Manchester

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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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.

Job Responsibility:

  • 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
  • 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
  • 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
  • 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
  • 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
  • Assist in developing and managing cGMP and Quality Assurance systems for radiopharmaceutical production
  • Maintain production training to support validation activities
  • Complete media fill training as required
  • Manage chemical stock, preparation, safe storage, and disposal for validation projects
  • Prepare and update SOPs in line with relevant guidelines
  • 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
  • Collaborate with operational and project teams to develop and introduce new products
  • Operate cyclotron and produce radioisotopes
  • Synthesize radiolabelled PET tracers
  • Follow clean room protocols for aseptic/sterile dispensing
  • Undertake Radiation Protection Supervisor (RPS) training
  • Follow site radiation safety rules and health & safety procedures
  • Liaise with RPA and DGSA to ensure regulatory compliance
  • Support regulatory submissions and act as SME during audits
  • Adhere to GMP, GLP, and safety protocols from MHRA, EA, HSE/ONR

Requirements:

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

Additional Information:

Job Posted:
December 17, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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