Gene Therapy Compliance Specialist

1 day ago

Cebu City, Central Visayas, Philippines beBeeCompliance Full time ₱900,000 - ₱1,200,000
Gene Therapy QA Compliance Specialist

Smartsourcing seeks a detail-oriented Quality Assurance Project Manager to ensure compliance with FDA regulations, oversee documentation accuracy, and support clinical and preclinical programs.

  1. Regulatory Compliance:
  • Review technical documents for compliance with FDA and international standards.
  • Monitor and address compliance with regulatory requirements for manufacturing and clinical documentation.
Documentation Oversight:
  • Manage 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.
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 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.
Required Skills and Qualifications
  • Bachelor's degree in biology, biotechnology, or Science-related field; or a master's degree.
  • Significant experience in QA/QC within pharmaceutical research and development setting is essential for 2-4 years.
  • Understanding of FDA regulatory requirements and quality standards.
  • Experience with clinical and preclinical documentation, including manufacturing specifications.
  • Exceptional organizational and analytical skills with keen attention to detail.
  • Proactive approach to work.
  • Proficient in using project management tools and document control systems.
  • Excellent communication skills for coordinating across teams and stakeholders.
Benefits
  • Fixed weekends off.
  • 5-day Christmas Leave.
  • HMO coverage from Day 1 of employment.
  • Group life insurance from Day 1 of employment.
  • Free lunch and soft breakfast every day.
  • Free coffee every day made by our in-house barista.
  • Night shift differential.
  • Sports wellness clubs.
  • Subsidised gym membership at Anytime Fitness.
  • Engagement bonuses.
  • Over-the-top monthly, quarterly, and annual performance bonuses.
  • Exclusive discounts in selected restaurants and merchants.
  • Themed events, summer parties, and community give-back programs.
About Smartsourcing

Smartsourcing believes the best work comes from people who feel seen, heard, and valued. We foster an environment where you can be your true self. Certified as a Great Place to Work, we know that when you love where you work, extraordinary things happen. At Smartsourcing, you'll find a culture that inspires growth, innovation, and authenticity.

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