QA & Validation Manager

ARx Recruitment Services; Manchester; On-site; GBP 75,000 - 110,000; Full time

Job summary

ARx Recruitment Services in the United Kingdom seeks a QA and Validation Manager reporting to the Head of Quality UK. You will be located at a choice of UK locations and responsible for QA and Validation across seven sites, ensuring GMP, GDP and MHRA compliance.

You will provide strategic oversight with hands-on regulatory input, lead cross-site teams, and drive continuous improvement while supporting regulatory inspections and the implementation of a new electronic Quality Management System.

Qualifications

• Degree or higher in Validation or equivalent experience in a pharmaceutical setting.
• Minimum 5 years' experience in validation.
• Previous managerial or supervisory experience with a demonstrable track record of strong performance.
• Proven track record of working and networking across multiple sites and motivating teams on site and remotely.
• Proven QA and Validation experience within Nuclear Medicine, Sterile Manufacturing or Aseptic Processing Environments.
• Strong working knowledge of UK and EU GMP, MHRA regulatory requirements and GxP compliance.

Responsibilities

• Lead QA and Validation across seven UK sites.
• Interface QA, Regulatory Affairs, Operations and QC to maintain standards.
• Provide strategic oversight with hands-on regulatory input.
• Harmonise validation including deviations, CAPA, change control, and risk management.
• Attend global quality management meetings and track actions.
• Ensure inspection readiness and participate in regulatory audits.
• Advise site teams on validation, projects and continual improvements.
• Support implementation of a new electronic QMS.
• Drive continuous improvement and quality culture across the network.
• Lead QA validation for commercial and IMP activities.
• Support MHRA and other authorities' interactions.
• Review and approve SOPs, batch docs, validation protocols and reports.

Skills

QA leadership

Cross-site coordination

Regulatory knowledge

GMP/GDP knowledge

Stakeholder management

Communication

Education

Degree in Validation

Pharmaceutical degree

Tools

Microsoft Word

Microsoft Excel

Quality Management System

Job description

Reporting to the Head of Quality UK, the QA and Validation Manager can be Located at a Choice of Company UK Locations and will have Responsibility for the Quality Assurance Projects Team

ROLE

• Providing Quality and Validation Leadership, Across Seven UK Licensed Sites, with Accountability for All Site Validations and Consistent Applications of GMP, GDP and MHRA Requirements
• Key interface between Quality Assurance, Regulatory Affairs, Operations and Quality Control, Ensuring Consistent Standards, Robust Systems and Inspection Readiness Across the Network
• Combining Strategic Oversight with Hands-On Regulatory Input, Supporting Routine Commercial Operations and Development Programmes
• Building and Maintaining Good Working Relationships Across the Sites and Overseeing and Harmonising Validation, Including Deviations, CAPA's, Change Control, Documentation and Risk Management
• Attendance at Global Quality Management Meetings and Tracking Actions to Ensure Timely Closure
• Ensure Inspection Readiness and Direct Participation in Client Audits and Inspections by Regulatory Authorities
• Act as Advisor to Site Teams in Aspects of Validation, Projects and Quality Continual Improvements
• Working Alongside Head of Quality to Implement a New Electronic Document/Quality Management System
• Supporting Head of Quality in Driving Continuous Improvement, Inspection Readiness and Quality Culture across UK Network
• Act as the QA Validation Lead for Commercial and IMP Activities
• Support Regulatory Interactions with MHRA and Other Authorities, Including Inspections, Audits, Responses and Ongoing Compliance Commitments
• Provide QA Input to Product Development, Technology Transfer and Validation Activities
• Review and Approve Quality and Regulatory Documentation, Including SOP's, Batch Documentation, Validation Protocols and Development Reports

REQUIRED

• Degree or Higher in Validation or Equivalent Experience in a Pharmaceutical Setting
• Strong Background in Validation, with a Minimum of 5 Years' Experience
• Previous Managerial or Supervisory Experience with a Demonstrable Track Record of Strong Performance
• Proven Track Record of Working and Networking Across Multiple Sites and Motivating Teams on Site and Remotely to Implement Consistent Quality Standards at Scale
• Proven QA and Validation Experience within Nuclear Medicine, Sterile Manufacturing or Aseptic Processing Environments.
• Demonstrable Experience Supporting Commercial and IMP Product Development
• Strong Working Knowledge of UK and EU GMP, MHRA Regulatory Requirements and GxP Compliance
• Background in Regulatory Inspections, Audits and Authority Interactions within a Licensed Manufacturing Environment
• Experience Collaborating Cross-Functionally with Manufacturing, Quality Control, Development and Clinical Teams
• Confident and Capable Communicator, (Spoken and Written), with Ability to Operate at Both Operational and Senior Stakeholder Level
• Self-Motivated, Proactive, with Demonstrable Lead by Example Skills
• Experienced in Microsoft Windows, Word, Excel and PowerPoint