Regulatory Affairs Leader for Gene Therapies
2 days ago
Pure Resourcing Solutions
Estimated Salary: £60,000 - £80,000 per annum
About the Role:
We are seeking an experienced Regulatory Affairs professional to lead our Gene Therapy Compliance team. This is a unique opportunity to develop and implement process development compliance for gene therapies.
Key Responsibilities:
- Ensure Quality Management System (QMS) compliance in accordance with relevant regulations and industry standards.
- Investigate and resolve non-conformities, including conducting root cause analysis and implementing corrective actions.
- Lead Site Management Review meetings to ensure compliance with regulatory requirements.
- Develop and maintain quality reports to track performance and identify areas for improvement.
- Collaborate with cross-functional teams to ensure seamless integration of QA activities into product development and manufacturing processes.
Requirements:
- Degree in Life Sciences or a related field.
- Significant experience in cell and/or gene therapy product manufacture, preferably in a leadership role.
- Thorough understanding of Good Manufacturing Practice (GMP) and Advanced Therapy Medicinal Products (ATMPs).
- Able to lead and deputise for senior management.
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