Director Quality Operations - Valneva : Job Details

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 to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to 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.

We are recruiting for our new Director of Quality.

Valneva's mission is to help protect lives worldwide through the discovery, development, and commercialization of innovative vaccines against infectious diseases, in compliance with current GxP regulation. The incumbent will support the company's vision and mission by acting with integrity, in a compliant, respectful, customer-centered, accountable, and compassionate manner to achieve strategic goals.

This role is hands-on and involves interaction with internal and external stakeholders across all functions to ensure and oversee quality in the manufacture and supply of vaccines and materials used in clinical trials.

The role includes ensuring operations comply with internal and external quality and regulatory standards by leading the integrated quality function (QA Operations, Validation, Quality Systems, QC, Regulatory Compliance & Risk Management) and acting as the local contact for Regulatory Affairs activities related to Livingston site licensing, product licenses, and registered processes.

Responsibilities include acting as a UK Qualified Person on the UK MIA(H) and MIA(IMP) licenses, Responsible Person for Importation (RPi) on the UK WDA(H) license, and supporting RPs and other QPs as the Lead QP.

The position involves leading the site's Quality and compliance functions, managing local Quality teams, overseeing the local Quality Management System (QMS), preparing for GMDP inspections, ensuring regulatory compliance, and representing site quality in various leadership and governance bodies.

Experience

• Bachelor's degree in Life Sciences with 8-10 years' experience in the life science or pharmaceutical industry, ideally including vaccines; a Master's degree or higher is preferred.
• At least 5 years' senior management experience in Quality Assurance, Quality Systems, and Quality Control within GxP regulated environments.
• Experience as a QP / RPi in the EU and UK is desirable; eligibility to become an RP/QP is required.
• Experience hosting UK MHRA and other global regulatory inspections.
• Deep knowledge of GxP legislation (GMP, GDP, GCP, GCLP) for the UK, EU, US, and other markets.
• Experience working in an international, multilingual environment is desirable.

Required Skills

• Strong leadership and management skills, with the ability to motivate teams.
• High ethical standards and extensive knowledge of quality and regulatory standards.
• Open-minded, innovative, and team-oriented.
• Excellent communication and influencing skills.
• Ability to work cross-functionally across various departments.
• Proactive, flexible, and solution-oriented in a fast-changing environment.
• Decisive, compliant decision-making skills.
• Analytical, structured, and scientific approach to information.
• Strong workload management and prioritization skills.
• Excellent English; additional languages are a plus.

• Stock Options
• Employee Assistance Programme
• Gym membership or fitness allowance
• LinkedIn Learning access
• EV Salary Sacrifice scheme
• And many other benefits