Gene Therapy QA Compliance Manager

Join the Team That's Changing the Game – Smartsourcing's 4-Time Best Company to Work For

Hi We're Smartsourcing, and we're looking for a Gene Therapy QA Compliance Manager to join our team full-time, on-site. This is your chance to experience a work culture where growth, innovation, and authenticity are not just buzzwords—they're how we do things every day.

Where? Crown 7 Business Centre, Pope John Paul II Ave, Cebu City, Cebu/ JEG Tower, Archbishop Reyes, Corner Acacia St., Barangay Kamputhaw, Cebu City, 6000 Cebu

About the Role of Gene Therapy QA Compliance Manager

Our partners, a leading preclinical stage gene therapy company focused on neuromuscular junction diseases, is seeking a detail-oriented Quality Assurance Project Manager. This role will ensure compliance with FDA regulations, oversee documentation accuracy, and support their 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.

Key Responsibilities

1. 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.

• 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).

• Identify and document gaps in quality or compliance in existing processes.
• Draft detailed summaries and quality reports for management and regulatory submission.

• 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.

• 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.

About You

Must-Have Qualifications

• Minimum requirement: Bachelor's degree in biology, biotechnology, or a Science-related field; or a master's 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.

Step Into the Smartsourcing Experience

Smartsourcing was created with one mission: to change lives. We're here to ensure that businesses flourish and, just as importantly, that every member of the crew is inspired, supported, and set up to thrive. For the fourth year running, we've been recognized as one of HR Asia's Best Companies to Work For. This award isn't just a title—it's a testament to our commitment to making Smartsourcing an incredible place to build a career.

Why You'll Love Working Here

At Smartsourcing, we believe the best work comes from people who feel seen, heard, and valued. That's why we're all about fostering an environment where you can be your true self. We take pride in being certified as a Great Place to Work, because we know that when you love where you work, extraordinary things happen. Here's just a glimpse of what we offer:

• Fixed weekends off
• 5-day Christmas Leave
• HMO coverage for you and your dependent/s from Day 1 of employment
• Group life insurance from Day 1 of employment
• Free lunch + soft breakfast every day
• Free coffee every day (latte, americano, or cappuccino) made by our in-house barista
• For the night shifters, additional NIGHT DIFF
• Sports wellness clubs including hiking and free-diving
• 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 BFFs, monthly knockoffs, summer parties
• Community give-back programs and personal development workshops
• And so much more

Ready to build a smarter career with Smartsourcing? Apply now and be part of something bigger—where you are truly valued, every step of the way.