Head of Manufacturing

About Us

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.

Together, we are a global company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

About the Role

Our Manufacturing team has a fantastic new opportunity to join the team here in Livingston. The role involves coordinating the execution of manufacturing steps in accordance with defined procedures and protocols, adhering to cGMP work practices and quality standards. This position is dedicated to managing production and resources while ensuring effective managerial control of all production activities.

Key responsibilities include:

• Planning and coordinating manufacturing activities
• Collaborating with support functions to optimise operations
• Attending key site governance meetings and leading on occasion to ensure the department is moving forward with alignment to the company strategy
• Managing the interface between the Manufacturing Team and a team of highly experienced Development and Manufacture Scientists, to optimise commercial product manufacturing to ensure lean operations and meet supply requirements

This role is both tactical and strategic with a focus on the 1-12-month timeframe. Employee experience and retention are key KPIs to manage, whilst driving best working practices, in a busy department. Detailed root cause analysis to drive sustainable changes and improvements are also key.

Key Responsibilities

• 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 with 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.