Our partners, a leading preclinical stage gene therapy company focused on neuromuscular junction diseases, is seeking a detail-oriented Compliance and Quality Assurance Manager. This role will ensure compliance with FDA regulations, oversee documentation accuracy, and support their clinical and preclinical programs, including a gene therapy project.Responsibilities: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.
Qualifications:
Minimum requirement: Bachelors degree in biology, biotechnology, or a Science-related field; or a masters degree.
In the absence of a master's degree, significant experience in QA/QC within a pharmaceutical research and development setting is essential for 2-4 years
An understanding of FDA regulatory requirements and quality standards is a must
Experience with clinical and preclinical documentation, including manufacturing specifications.
Exceptional organizational and analytical skills with keen attention to detail.
This person should be a smart, self-motivated individual with a proactive approach to work.
Has experience in using project management tools and document control systems.
Excellent communication skills for coordinating across teams and stakeholders.
Work setup: Onsite, M-FLocation: Cebu CityBy Applying, you give consent to collect, store, and/or process personal and/or sensitive information for the purpose of recruitment and employment may it be internal to Cobden & Carter International and/or to its clients.
