This position can be based in the UK or Ireland (Travel expected between both sites)
Job Description:
Embark on a transformative career path as the Validation Director, a pivotal role where your expertise will shape the future of commercial and clinical manufacturing. This position, which can be based in the UK or Ireland, offers an unparalleled opportunity to develop and implement cutting-edge validation strategies and lead operational excellence in gene therapy manufacturing
Responsibilities:
* Lead validation strategies for facilities in Ireland and the UK, ensuring compliance with regulations and best practices.
* Act as the main contact during audits and inspections, communicating validation strategies effectively.
* Provide guidance on validation across departments, embedding risk management principles.
* Coach team members on best practices and ensure compliance with regulatory standards.
* Conduct gap analysis, review change controls, and develop revalidation strategies as needed.
* Ensure GMP, Data Integrity, and GDP compliance, including timely training.
Key Competencies:
* Proven track record in delivering regulatory-compliant validation strategies.
* Strong understanding of GxP compliance requirements.
* Excellent communication and issue escalation skills.
* Flexibility to adapt to business needs and experience with complex projects
* Proficiency in project planning software is desirable.
Apply Now!
If you have leadership experience in validation within biotechnology, apply today! If you would like to have an informal chat to discuss the role and our partner please send Harriet Robson a LinkedIn Message.