Regulatory Compliance Manager
4 days ago
Company Overview
Smartsourcing is a leading preclinical stage gene therapy company focused on neuromuscular junction diseases. We are seeking a detail-oriented Compliance and Quality Assurance Manager to join our team.
This role will ensure compliance with FDA regulations, oversee documentation accuracy, and support our clinical and preclinical programs, including a gene therapy project. The ideal candidate will have a background in quality assurance and project management within biotech or a related field.
Job Description
- Regulatory Compliance:
- Review and ensure all technical documents meet FDA and international standards for gene therapy.
- Monitor and address compliance with regulatory requirements for manufacturing and clinical documentation.
- Documentation Oversight:
- Manage and analyze product specifications, including those for plasma and viral vectors, ensuring compliance and consistency.
- Organize and maintain documentation repositories for easy access and auditing.
- Compare and reconcile manufacturing specifications across different scales (e.g., 2L to 50L).
- Quality Assurance:
- Identify and document gaps in quality or compliance in existing processes.
- Draft detailed summaries and quality reports for management and regulatory submission.
- Collaboration and Support:
- Work closely with the Program Director, manufacturing teams, and external partners.
- Facilitate cross-functional meetings to ensure alignment on quality standards and deliverables.
- Support team training on quality and compliance processes.
- Continuous Improvement:
- Identify opportunities for process improvements in document management and compliance workflows.
- Stay informed of updates in FDA guidelines and ensure internal processes align with evolving standards.
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