Regulatory Compliance Manager

4 days ago


Cebu City, Central Visayas, Philippines Smartsourcing Full time

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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