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.
Together, we are a global company that values diversity and inclusion. Our diverse workforce makes Valneva a great place to work.
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 regulations. The incumbent will support the company's vision and mission by acting with integrity, ensuring compliance, and fostering a respectful, customer-centered, and accountable environment to achieve strategic goals.
This role is hands-on and involves interacting with internal and external stakeholders across all functions to oversee quality in the manufacture and supply of commercial vaccines and in the production of vaccines and materials used in clinical trials.
The role includes ensuring all operations comply with internal and external quality and regulatory standards by leading and managing an 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.
The Director will act as a UK Qualified Person on the UK MIA(H) and MIA(IMP) licenses and as Responsible Person for Importation (RPi) on the UK WDA(H) license, as required. They will support RPs and other QPs on site by acting as the Lead QP.
Responsibilities include:
1. Leading site quality and compliance with pharmaceutical regulatory requirements; managing Quality Assurance and Quality Control teams.
2. Recruiting, leading, and developing local site Quality teams.
3. Managing the budget for the quality function.
4. Overseeing the site’s QMS and ensuring adherence to the Global QMS.
5. Preparing the site for GMDP inspections at all times.
6. Supporting Regulatory Compliance efforts and ensuring licensing conditions and guidance are followed.
7. Contributing to setting global GxP quality standards as part of the Global Quality Leadership Team.
8. Escalating quality issues to senior management.
9. Providing guidance on Quality, GxP, and regulatory compliance at the site.
10. Developing and reporting on key quality metrics to foster continuous improvement.
11. Chairing the Quality Review Board and representing Site Quality in executive and global governance bodies.
Experience
* Bachelor’s degree in Life Sciences; 8-10 years’ experience in life sciences or pharmaceuticals, preferably including vaccines. A Master’s degree or higher is preferred.
* At least 5 years’ senior management experience in QA, Quality Systems, and QC within GxP regulated environments.
* Experience as a QP / RPI in the UK and EU; eligibility to become a QP/RPI is required.
* Experience with UK MHRA and global regulatory inspections.
* Deep knowledge of GxP legislation (GMP, GDP, GCP, GCLP) in the UK, EU, US, and other markets.
* Experience working in international, multicultural teams 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 solutions-oriented.
* Sound decision-making aligned with business needs.
* Analytical and structured thinking skills.
* Effective workload management and prioritization.
* Fluent in English; additional languages are a plus.
Benefits include stock options, Employee Assistance Program, gym membership or fitness allowance, LinkedIn Learning, EV Salary Sacrifice scheme, among others.
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