Compliance and Quality Assurance Manager

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-F

Location: Cebu City

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