Compliance and Quality Assurance Manager

1 week ago

Cebu, Philippines Cobden & Carter International Full time

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

By 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.

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