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ValnevaPosted 1 week ago

Head of Manufacturing

On-siteLivingston, Scotland, United Kingdom

Full TimeSenior LevelMedium

Job Summary

Coordinate daily production schedules and manage manufacturing resources to ensure timely, compliant delivery of vaccines. Oversee execution of all production steps in strict adherence to cGMP standards, SOPs, and quality protocols while leading root cause analysis for sustainable improvements. Manage a team of experienced operatives and supervisors, driving continuous improvement through Lean Six Sigma projects and maintaining rigorous safety and cleanliness standards. Develop staff training plans, monitor key quality metrics, and handle deviations, change controls, and CAPAs to support regulatory submissions and site audits. Deputise for the line manager and lead site governance meetings to align departmental operations with Valneva's strategic goals for expanding global vaccine capacity.

Required Qualifications

  • Production Planning and Coordination: On a daily basis, plan, coordinate, and manage production schedules to ensure timely delivery of products that meet quality and cost objectives.
  • Compliance Oversight: Ensure all production steps defined by SOPs, production records, and protocols are executed in compliance with cGMP standards.
  • Best Practices Implementation: Oversee the application of best cGMP practices and techniques to ensure products are produced within specifications, ensuring that all equipment, facilities, and materials comply with defined standards.
  • Staff Training and Competence: Ensure all production staff are adequately trained and competent in their procedures, consistently adhering to cGMP working practices.
  • Training Development: Develop and implement a training plan to enhance the skills of current production personnel and facilitate rapid onboarding of new staff.
  • Key Metrics Management: Be responsible for the development, collection, and reporting of key quality and business metrics, using these metrics to foster a culture of continuous improvement.
  • Deviation Management: Ensure that any deviations, change controls, or CAPAs related to materials, facilities, processes, or procedures are escalated and addressed promptly.
  • Work Environment Maintenance: Liaise with manufacturing staff to maintain cleanliness, organisation, and continuous inspection readiness in all production areas.
  • Safety Compliance: Conduct all activities safely and in full compliance with HSE requirements.
  • Team Environment: Actively contribute to creating and maintaining an enthusiastic, supportive, and collaborative team environment.
  • Leadership Duties: Deputise for the line manager, if needed and undertake additional duties as requested in accordance with company requirements.
  • Project Management: Effectively manage assigned projects and sub-project workstreams, ensuring delivery within agreed timelines.
  • Team Management: Manage a team of experienced operatives and supervisors, ensuring ownership and timely delivery of project tasks and responsibilities.
  • Process Development and Improvement: Identify improvement projects, focusing on enhancing process robustness, yield, and cost-effectiveness.
  • Regulatory Preparedness: Support regulatory submissions and ensure departmental readiness for associated audits.
  • Continuous Improvement Strategy: Define and implement a continuous improvement strategy aligned with the long-term strategic goals of the organisation.
  • Lean Six Sigma Projects: Use Lean Six Sigma methodology to identify, manage, and deliver key improvement projects throughout the business.
  • Change Management: Ensure effective implementation of change management techniques and procedures where necessary.
  • Risk Consideration: Assess risks and ensure alignment with organisational strategy in all projects.
  • Project Planning: Generate project plans that identify commercial considerations, impacts, milestones for delivery, and associated business benefits. Ensure work plans are aligned with business requirements and site projects, goals and objectives.
  • Quality Management System: Manage and track the timely delivery of department-owned Quality Management System actions and documentation.
  • Escalation of Compliance Issues: Escalate deviations to compliance through appropriate Quality Management Systems and the site Senior Leadership Team.
  • Training Standards Maintenance: Ensure departmental training standards are consistently maintained.
  • Safety and Quality Advocacy: Promote and act as an ambassador for safety and quality excellence across teams and site-wide.
  • Knowledge Sharing Culture: Foster a culture of knowledge sharing within teams to enhance collective experience.
  • Leadership Excellence: Lead by example in maintaining a collaborative environment across the team and sites.
  • Flexibility and Additional Duties: Be prepared for shift work and out-of-hours responsibilities as required, and undertake any other duties as requested by the line manager.
  • Budget Management: Effectively manage all budgets associated the Manufacturing Department. Work with the Director of Operations on setting budgets and manage in accordance. Highlight areas for cost savings and implement as routine.

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